Apparatus and method for securing a suture

ABSTRACT

The present invention provides a method of securing a suture. The method includes providing a retainer having first and second sections. The first section has a central post, and the second section has a central bore dimensioned to receive the central post. The method also includes moving a suture through a passage in the first section, wrapping the suture around the central post, and moving the suture through a channel of the second section. The method further includes interconnecting the first and second sections with the central post positioned in the central bore and with the suture disposed between the first and second sections. Moreover, the method includes bonding the first and second sections together to secure the suture relative to the retainer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/465,199 filed on Aug. 17, 2006, which in turn is a continuation ofU.S. patent application Ser. No. 10/228,855 filed on Aug. 27, 2002 (nowU.S. Pat. No. 7,094,251). Priority to both U.S. patent application Ser.Nos. 11/465,199 and 10/228,855 is claimed under 35 U.S.C. § 120.

BACKGROUND

The present invention relates to a new and improved apparatus and methodwhich are used to secure a suture relative to body tissue.

It has previously been suggested that a retainer may be connected with asuture by applying energy to the retainer. The energy effects a bondingof one portion of the retainer to another portion of the retainer. Ithas previously been suggested that a retainer could be connected with asuture in the manner disclosed in Japanese laid-open Patent ApplicationNo. 8-140,982 and in U.S. Pat. Nos. 6,010,525; 6,174,324; and 6,368,343.

SUMMARY OF THE INVENTION

The present invention relates to a new and improved apparatus and methodfor use in securing a suture. The suture is positioned relative tosections of an improved retainer. The sections of the retainer areinterconnected when the retainer has been positioned relative to apatient's body tissue. The sections of the retainer may be bondedtogether by the application of energy to the retainer by an improvedapplicator assembly.

The improved retainer may have one or more projections which engage oneor more recesses to position the sections of the retainer relative toeach other. An interference fit may be provided between one or moreprojections and one or more recesses to hold the sections of theretainer in a desired spatial relationship. The projections may havesurfaces which at least partially define one or more passages and guidemovement of one or more portions of the suture relative to the retainer.In addition, the surfaces on the projections may function to positionthe suture relative to the retainer.

The improved applicator assembly may be used to apply energy to theretainer. Energy applied to the retainer may effect bonding of endportions of the projections to bottom portions of recesses in theretainer. The end portions of the projections may function as energydirectors which concentrate energy. If desired, one or more loops may beformed in the suture around one or more of the projections.

The applicator assembly may grip the retainer with a predeterminedforce. While the applicator assembly grips the retainer, the applicatorassembly may be utilized to slide the retainer along the suture toposition the retainer relative to body tissue. While the applicatorassembly is gripping the retainer, the applicator assembly may applyenergy to the retainer to effect bonding of sections of the retainertogether. The applicator assembly may be used to move the retainer intoa cannula to engage tissue in a patient's body.

The present invention includes a plurality of different features whichmay be utilized in combination with each other or separately. Thevarious features of the invention may be used in combination withfeatures of the prior art. For example, the improved retainer may beused with the improved applicator assembly or with a prior artapplicator assembly. As another example, the improved applicatorassembly may be used with the improved retainer or a prior art retainer.As still another example, the retainer may be moved through a cannula toa desired position relative to body tissue or may be positioned relativeto the body tissue without being moved through a cannula.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the invention will become moreapparent upon consideration of the following description taken inconnection with the accompanying drawings wherein:

FIG. 1. is a fragmentary schematic illustration depicting the manner inwhich a suture and an improved retainer are positioned relative to bodytissue;

FIG. 2. is an enlarged schematic pictorial illustration of the retainerof FIG. 1;

FIG. 3. is an exploded schematic pictorial illustration depicting theconstruction of a base section and cover section of the retainer ofFIGS. 1 and 2;

FIG. 4. is an exploded schematic pictorial illustration, furtherillustrating the construction of the base and cover sections of theretainer;

FIG. 5. is an exploded schematic pictorial illustration, furtherillustrating the construction of the base and cover sections of theretainer;

FIG. 6. is an exploded schematic pictorial illustration furtherillustrating the construction of the base and cover sections of theretainer;

FIG. 7. is a schematic sectional view depicting the relationship betweenthe base and cover sections of the retainer of FIGS. 1-6 with portionsof the suture disposed in passages in the retainer;

FIG. 8. is a schematic fragmentary sectional view, generally similar toFIG. 7, depicting the manner in which end portions of projections on thecover section of the retainer are bonded to bottom portions of recessesin the base section of the retainer;

FIG. 9. is a highly schematized sectional view illustrating theconstruction of an improved applicator assembly which is utilized tointerconnect sections of the retainer of FIGS. 1-7 in the mannerillustrated schematically in FIG. 8;

FIG. 10. is a schematic pictorial illustration of one embodiment of theapplicator assembly of FIG. 9;

FIG. 11. is an enlarged fragmentary schematic pictorial illustration ofa portion of the applicator assembly of FIG. 10, illustrating a triggerand spring housing;

FIG. 12. is an enlarged fragmentary schematic illustration of an endportion of the applicator assembly of FIG. 10;

FIG. 13. is a schematic illustration depicting the manner in which asuture may be looped around projections on the retainer of FIGS. 1-8;

FIG. 14. is a schematic sectional view, generally similar to FIG. 7illustrating a second embodiment of the retainer;

FIG. 15. is a schematic illustration, taken generally along the line of15-15 of FIG. 14, illustrating a relationship of the suture to a coversection of the retainer;

FIG. 16. is a schematic illustration, generally similar to FIG. 15,illustrating the manner in which the suture may be looped aroundprojections on the cover section of the retainer;

FIG. 17. is a schematic sectional view of another embodiment of theretainer;

FIG. 18. is a schematic sectional view of another embodiment of theretainer;

FIG. 19. is a schematic sectional view of another embodiment of theretainer;

FIG. 20. is a schematic plan view of another embodiment of the retainer;

FIG. 21. is a schematic sectional view, taken generally along the line21-21 of FIG. 20, further illustrating the construction of the retainer;

FIG. 22. is a schematic sectional view of another embodiment of theretainer;

FIG. 23. is a schematic sectional view of another embodiment of theretainer;

FIG. 24. is a fragmentary schematic illustration depicting the manner inwhich the applicator assembly of FIGS. 9-12 may be utilized to move theretainer of FIGS. 1-8 and 13-23 into a cannula; and

FIG. 25. is a fragmentary schematic illustration, generally similar toFIG. 12, depicting the manner in which a shield may be provided on thedistal portion of the applicator assembly of FIGS. 9-12.

DESCRIPTION OF SPECIFIC PREFERRED EMBODIMENTS OF THE INVENTION

Suture Retainer

An improved retainer 30 is utilized to fixedly interconnect oppositeportions 32 and 34 of a suture 36. The portions 32 and 34 of the suture36 extend in opposite directions through the retainer 30. Anintermediate portion 38 of the suture extends between the portions 32and 34 and extends around body tissue 40 to the retainer 30. It shouldbe understood that the suture 36 and retainer 30 could be connected witheach other and/or the body tissue 40 in a manner which is different thanthe specific manner illustrated in FIG. 1. For example, the portions 32and 34 of the suture 36 may extend in the same direction from theretainer 30.

It is contemplated that the suture 36 and retainer 30 may be utilized tosecure body tissue 40 in many different ways. For example, the suture 36and retainer 30 may be utilized to secure one piece of body tissue toanother piece of body tissue. The suture 36 and retainer 30 may beutilized to secure soft body tissue to hard body tissue (bone). Thesuture 36 and retainer 30 may be utilized to connect hard body tissue tohard body tissue in the manner disclosed in U.S. Pat. No. 6,238,395. Thesuture 36 and retainer 30 may be disposed entirely within a patient'sbody or may engage a surface area on the patient's body.

It is contemplated that the suture 36 can be constructed of a singlefilament or of a plurality of filaments. The suture 36 may be formed ofbiodegradable or nonbiodegradable material. Similarly, the retainer 30may be formed of biodegradable or nonbiodegradable material.

It is believed that it may be desired to form the retainer 30 fromPoly-L-Lactic Acid (PLLA) or other resorbable polymer. Although it isbelieved that it may be desired to form the retainer 30 and suture 36 ofthe same material, the retainer and suture may be formed of differentmaterials. For example, the suture 36 and retainer 30 may both be formedof a biodegradable material. Alternatively, one of the suture 36 andretainer 30 may be formed of a biodegradable material and the other oneformed of a nonbiodegradable material.

It is contemplated that the suture 36 and retainer 30 may be positionedrelative to the body tissue 40 using laproscopic or arthroscopicsurgical procedures. The retainer 30 and suture 36 may be moved into apatient's body through a cannula. Fiber optics may be used inassociation with the cannula to facilitate positioning of the suture 36and retainer 30. The cannula may have any one of the constructionsdisclosed in U.S. Pat. Nos. 6,338,730 and 6,358,266. The positioning ofthe retainer 30 and suture 36 using endoscopic surgical procedures maybe preferred in order to minimize the size of an incision in a patient'sbody. Of course, the retainer 30 and suture 36 may be used with an openincision which is relatively large.

Regardless of whether the retainer 30 and suture 36 are positioned in apatient's body using open or minimally invasive surgical techniques, itis contemplated that it may be desired to tension the suture 36 with apredetermined force. A predetermined tension is applied to the suture 36by pulling the portions 32 and 34 of the suture from the retainer 30with a predetermined force. The suture 36 is tensioned with a forcewhich is a function of the size and strength of the suture.

The manner in which the suture 36 is tensioned with a predeterminedforce may be the same as is disclosed in U.S. Pat. No. 6,159,234 or inU.S. patent application Ser. No. 09/556,458 filed May 3, 2000 by PeterM. Bonutti and entitled Method And Apparatus For Securing Tissue. Thesuture 36 is tensioned with a predetermined force by pulling theportions 32 and 34 of the suture before securing the retainer 30 to thesuture to hold the suture. When the retainer 30 has been secured to thesuture 36 to hold the suture, the retainer grips the portions 32 and 34of the suture 36 to maintain a tension, corresponding to thepredetermined force, in the suture.

It is contemplated that a robotic mechanism may be utilized to positionthe retainer 30 and/or suture 36 relative to the body tissue. An imagingdevice may be utilized in association with the robotic mechanism tofacilitate positioning of the retainer 30 and suture 36 relative to thebody tissue. The robotic mechanism and/or imaging device may have anyone of the constructions and be used in any one of the ways disclosed inU.S. patent application Ser. No. 10/102,413 filed Mar. 20, 2002 by PeterM. Bonutti and entitled Methods of Securing Body Tissue. During thesurgery, the patient may be covered by a drapery system which isconnected with a surgeon so as to maintain a sterile field between thesurgeon and the patient in the manner disclosed in U.S. patentapplication Ser. No. 09/941,185 filed Aug. 28, 2001 by Peter M. Bonuttiand entitled Method of Performing Surgery. Of course, any desiredsterile drapery system may be provided to cover the patient.

In order to minimize the size of an incision in the patient, it iscontemplated that minimally invasive surgical techniques disclosed inthe aforementioned U.S. patent application Ser. No. 09/941,185 filedAug. 28, 2001 by Peter M. Bonutti and entitled Method of PerformingSurgery may be utilized. It is believed that the utilization ofminimally invasive surgical techniques may be particularly advantageouswhen used in association with a robotic mechanism and/or imagingapparatus in the manner disclosed in U.S. patent Ser. No. 10/102,413filed Mar. 20, 2002 by Peter M. Bonutti. It is contemplated that amagnetic suturing system having a construction similar to that in U.S.patent application Ser. No. 10/005,652 filed by Peter M. Bonutti on Dec.3, 2001 and entitled Magnetic Suturing System and Method may be used toposition the suture 36.

The retainer 30 includes a lower or base section 46 (FIGS. 2 and 3) andan upper or cover section 48. The portions 32 and 34 of the suture 36extend through passages 52 and 54 (FIGS. 2 and 7) formed between theupper and lower sections 46 and 48 of the retainer 30. The passages 52and 54 have a cross sectional area which is slightly greater than thecross sectional area of the suture 36 (FIG. 7). Therefore, the portions32 and 34 of the suture 36 can be readily pulled through the passages 52and 54 when the retainer 30 is in the initial or undeformed conditionillustrated in FIG. 7. It should be understood that the passages 52 and54 could have a configuration other than the configuration illustratedin FIG. 7.

Once the suture 36 has been tensioned with a desired force, the retainer30 is plastically deformed in the manner illustrated schematically inFIG. 8. This results in the portions 32 and 34 of the suture 36 beingsecurely gripped between the lower and upper sections 46 and 48 of theretainer 30. The portions 32 and 34 of the suture 36 are gripped with aclamping action which holds them against movement relative to each otherand to the retainer 30. This results in the desired tension beingmaintained in the suture 36.

The lower section 46 of the retainer 30 includes a right (as viewed inFIG. 3) recess 58 and a left recess 60. The right and left recesses 58and 60 have the same configuration and are disposed the same distancefrom a central axis of the circular lower section 46 of the retainer 30.Although the recesses 58 and 60 could have many differentconfigurations, the illustrated recesses have elongated configurationswith parallel longitudinal central axes which extend perpendicular tothe central axis of the circular lower section 46.

The upper section 48 has a circular body 64 from which right (as viewedin FIG. 3) and left projections 66 and 68 extend. The right and leftprojections 66 and 68 have the same cross sectional configuration whichcorresponds to the cross sectional configuration of the recesses 58 and60 (FIGS. 4, 5, 6, and 7). The projections 66 and 68 have an elongatedconfiguration with parallel longitudinal central axes which extendperpendicular the central axis of the circular body 64 of the uppersection 48 of the retainer 30. The projections 66 and 68 are disposedthe same distance from a central axis of the upper section 48. It iscontemplated that the projections 66 and 68 could have a configurationwhich is different than the specific configuration illustrated in FIGS.4-7.

A center projection 72 is disposed on the lower section 46 of theretainer 30 at a location midway between the right and left recesses 58and 60 (FIGS. 3, 4 and 7). The left and right projections 66 and 68 onthe upper section 48 of the retainer 30 are telescopically received inthe right and left recesses 58 and 60 in the lower section 46 of theretainer 30 (FIGS. 2, 3, and 7). This results in the upper section 38 ofthe retainer being positioned in a coaxial relationship with the lowersection 36 of the retainer. The center projection 72 is disposed midwaybetween the right and left projections 66 and 68 when they engage theright and left recesses 58 and 60. The right and left recesses 58 and 60cooperate with the right and left projections 66 and 68 to orient theupper section of the retainer 48 with the longitudinal axes of the rightand left projections 66 and 68 extending parallel to the longitudinalaxis of the center section 72.

When the right and left projections 66 and 68 are disposed in the rightand left recesses 58 and 60 (FIG. 7), the center projection 72cooperates with the right and left projections to partially form thepassages 52 and 54. The bottom (as viewed in FIG. 7) of the passage 52is formed by a gripper surface area 78. The bottom of the passage 54 isformed by a gripper surface area 80.

The gripper surface areas 78 and 80 on the lower section 46 face and areparallel to gripper surface areas 82 and 84 (FIG. 7) on the uppersection 48. The gripper surface areas 78, 80, 82 and 84 cooperate withthe projections 66, 68 and 72 to define the parallel passages 52 and 54.The gripper surface areas 78, 80, 82 and 84 may be roughened or knurledto enhance their ability to grip the suture 36.

The right and left projections 66 and 68 have flat parallellongitudinally extending inner side surfaces 88 and 90 (FIGS. 4 and 7).The inner side surfaces 88 and 90 on the projections 66 and 68 extendperpendicular to the gripper surface areas 82 and 84 on the circularbody 64 of the upper section 48 of the retainer 30. In addition, theright and left projections 68 and 70 have outer side surfaces 92 and 94which extend parallel to the inner side surfaces 88 and 90.

The center projection 72 has parallel right and left side surfaces 96and 98 which extend perpendicular to the gripper surface areas 78 and 80on the lower section 46 (FIG. 4). When the right and left projections 66and 68 on the circular body 64 of the upper section 48 of the retainer30 are disposed in the right and left recesses 58 and 60 on the lowersection 46 (FIG. 7), the right and left side surfaces 96 and 98 on thecenter projection 72 extend parallel to the inner side surfaces 88 and90 on the right and left projections 66 and 68.

The passages 52 and 54 through the retainer 30 are formed by flatsurfaces on the lower and upper sections 46 and 48 of the retainer. Theflat side surfaces which form the parallel passages 52 and 54 areeffective to guide a leading end of a portion of a suture 36 as thesuture is inserted into the passage. Thus, the leading end of theportion 32 of the suture is directed by the side surfaces 78, 88, 82,and 98 (FIG. 7) formed on the lower section 46, right projection 66,body 64 and center projection 72 respectively. Similarly, the leadingend of the portion 34 of the suture 36 is directed by the side surfaces80, 90, 84 and 96 formed on the lower section 46, left projection 68,body 64 and center projection 72. By forming the passages 52 and 54 withelongated side surfaces, insertion of the portions 32 and 34 of thesuture 36 into the passages is facilitated. This is because once aportion 32 or 34 of the suture 36 has been inserted into one of thepassages 52 or 54, the side surfaces of the passage maintain the leadingend of the suture in a desired relationship with the passage as thesuture continues to be moved into the passage.

The center projection 72 is effective to position the portions 32 and 34of the suture 36 so that they are disposed on opposite sides of andequal distances from a central axis of the retainer 30. This results inoff setting movements being applied to the retainer 30 by forcestransmitted to the retainer from the portions 32 and 34 of the suture36. Therefore, there is little or no tendency for the retainer 30 torotate or flip relative to the body tissue 40.

The right and left projections 66 and 68 on the upper section 48 of theretainer 30 are disposed in the recesses 58 and 60 in the lower section46 of the retainer 78 (FIG. 7) during insertion of the portions 32 and34 of the suture 36 into the passages 52 and 54 in the retainer 30. Tohold the projections 66 and 68 in the recesses 58 and 60, there is aninterference fit between the projections and the recesses. Thus, thedistance between an outer side surface 102 of the right recess 58 (FIG.7) and an inner side surface 104 of the right recess is slightly lessthan the distance between the outer side surface 92 and inner sidesurface 88 on the right projection 66. The resulting interferencebetween the right projection 66 and the right recess 58 is effective tohold the right projection in the right recess.

Similarly, the left recess 60 has parallel outer and inner side surfaces110 and 112. The outer and inner side surfaces 110 and 112 of the leftrecess 60 are spaced apart by distance which is slightly less than thedistance between the outer side surface 94 and inner side surface 90 onthe left projection 68. When the left projection 68 is pressed into theleft recess 60, the resulting interference between the side surfaces 90and 94 on the projection 68 and the side surfaces 110 and 112 on therecess 60 hold the left projection in the left recess. The side surfaces102, 104, 110 and 112 on the recesses 58 and 60 extend parallel to theside surfaces 96 and 98 on the center projection 72 and perpendicular tothe gripper surface areas 78 and 80 on the lower section 46.

The interference fit between the projections 66 and 68 on the uppersection 48 of the retainer with the recesses 58 and 60 in the lowersection 46 of the retainer holds the two sections of the retaineragainst movement relative to each other during insertion of the portions32 and 34 of the suture 36 into the passages 52 and 54. However, it iscontemplated that the upper section 48 and lower section 46 of theretainer 30 may be held against movement relative to each other by meansother than an interference fit. For example, latch surfaces on theprojections 66 and 68 may engage latch surfaces formed on the sides ofthe recesses 58 and 60. These latch surfaces may have a generally wedgeshaped configuration. Alternatively, a pin may extend through at least aportion of the lower section 46 of the retainer and the projections 66and 68 on the upper section 48 of the retainer to hold the upper sectionagainst movement relative to the lower section.

The lower section 46 and upper section 48 of the retainer 30 are formedas two separate pieces. However, it is contemplated that the lower andupper sections 46 and 48 of the retainer 30 could be formed as onepiece. If this is done, relatively weak connectors may be providedbetween the projections 66 and 68 and the base section 46 to hold thebase and upper sections 46 and 48 in a desired spatial relationship witheach other during insertion of the portions 32 and 34 of the suture 36into the passages 52 and 54. The weak connectors may be broken to enablethe portions 32 and 34 of the suture 36 to be gripped between theretainer sections 46 and 48. Alternatively, a flexible strap may beformed between the base section 46 and upper section 48. By deflectingthe strap, the projections 66 and 68 may be inserted into the recesses58 and 60.

When the right and left projections 66 and 68 are telescopicallyinserted into the right recess 58 and left recess 60, the leading orlower (as viewed in FIG. 7) end portions of the projections engage flatbottom surfaces 118 and 120 of the recesses 58 and 60 (FIG. 7). The flatbottom surfaces 118 and 120 extend parallel to the gripper surface areas78 and 80 on the lower section 46 and perpendicular to the side surfaces102, 104, 110 and 112 of the recesses 58 and 60. Engagement of endportions 124 and 126 of the projections 66 and 68 with the bottomsurfaces 118 and 120 of the recesses 58 and 60 positions the lower andupper sections 46 and 48 of the retainer relative to each other anddetermines the size of the passages 52 and 54. This results in thepassages 52 and 54 being sized so as to have a cross sectional areawhich is slightly greater than the cross sectional area of the portions32 and 34 of the suture 36 to enable the suture to be readily insertedinto the passages.

The center projection 72 has a flat upper side surface 130 which extendsparallel to the gripper surfaces 78, 80, 82 and 84. The upper sidesurface 130 on the center projection 72 is spaced from the upper section48 when the end portions 124 and 126 of the projections 66 and 68 are inengagement with the bottom surfaces 118 and 120 of the recesses 58 and60. However, if desired, the center projection 72 may be disposed inengagement with the upper section 48 when the end portions 124 and 126of the projections 66 and 68 are in engagement with the bottom surfaces118 and 120 of the recesses 58 and 60.

When the end portions 124 and 126 of the projections 66 and 68 are inengagement with the bottom surfaces 118 and 120 of the recesses 58 and60, the portions 32 and 34 of the suture 36 can be freely moved in thepassages 52 and 54 to enable the retainer 60 to be slid along the suture36 to a desired position relative to the body tissue 40. The retainer 30may be slid along the suture 36 under the influence of force manuallyapplied against the retainer or under the influence of force appliedagainst the retainer by a surgical instrument, such as forceps. As thisoccurs, the intermediate portion 38 (FIG. 1) of the suture is tightenedaround the body tissue with a desired force.

Once the retainer 30 has been positioned in a desired location relativeto the body tissue 40 and the suture 36 tensioned with a predeterminedforce, the retainer is plastically deformed from the initial conditionillustrated in FIG. 7 to the condition illustrated in FIG. 8. Plasticdeformation of the retainer 30 results in the size of the passages 52and 54 being decreased. In addition, the upper side 130 on the centerprojection 72 moves into engagement with the upper section 48 of theretainer 30. Engagement of the center projection 72 with the uppersection 48 of the retainer 30 tends to limit the extent to which thelower and upper section 46 and 48 of the retainer are pressed togetherto thereby limit plastic deformation of the retainer 30.

If the retainer 30 is constructed so that the center projection 72engages the upper section 48 of the retainer when the end portions 124and 126 of the projections 66 and 68 are in engagement with the bottomsurface areas 118 and 120 of the recesses 58 and 60, the centerprojection would also be deformed when the retainer is plasticallydeformed from the initial condition of FIG. 7 to the condition of FIG.8. With this construction of the retainer 30, the center projection 72would be deformed to the same extent as the projections 66 and 68.Therefore, the center projection 72 may be formed with an upper endportion which has the same configuration as the lower end portions 124and 126 of the projections 66 and 68.

To plastically deform and interconnect the lower and upper sections 46and 48 of the retainer 30, a member 140 (FIG. 8) is moved into a groove142 in the lower section 46. In addition, a second member 144 engages aflat outer side surface 146 on the upper section 48 of the retainer 30.The lower and upper sections 46 and 48 of the retainer 30 are firmlypressed together by force transmitted between the members 140 and 144through the retainer. While the lower and upper sections 46 and 48 ofthe retainer 30 are gripped between the members 140 and 144 with aclamping action, energy is transmitted from the member 144 to theretainer 30.

The energy applied to the retainer 30 is effective to heat the endportions 124 and 126 of the projections 66 and 68 into a transitiontemperature range for the polymeric material of the projections. Forceapplied against the retainer 30 by the members 140 and 144 (FIG. 8)causes the heat softened material of the projections 66 and 68 to flowin the recesses 58 and 60. To a lesser extent, material of the lowersection 46 is heated and also flows in the recesses 58 and 60.

As this occurs, the heated material of the projections 66 and 68 may beforced upward toward the portions 32 and 34 of the suture 36. The heatedmaterial tends to bond to the portions 32 and 34 of the suture 36. itshould be understood that the extent of deformation and flow of the heatsoftened material of the projections 66 and 68 may be and probably willbe greater than the extent illustrated schematically in FIG. 8.

If the retainer 30 is constructed so that the center projection 72 isdeformed to the same extent as the projections 66 and 68, heat softenedmaterial of the center projection would flow into the passages 52 and54. If the upper section 48 of the retainer 30 has the constructionshown in FIG. 4, the upper end portion of the center projection wouldengage the flat lower side surface of the body 64. However, the uppersection 48 of the retainer 30 may be formed with a recess to receive theupper end portion of the center projection 72. This recess may have thesame configuration as the recesses 58 and 60 in the lower section 46 ofthe retainer 30.

If desired, the retainer 30 may be constructed with the centerprojection 72 extending from the upper section 48 of the retainer. Ifthis is done, the center projection 72 from the upper section 48 of theretainer may have the same configuration as the illustratedconfiguration of the center projection in FIGS. 4 and 5. A recess may beprovided in the lower section 46 to receive a portion of a centerprojection from the upper section 48 of the retainer 30.

As the heated material of the projections 66 and 68 is caused to flow inthe recess 58 and 60, the size of the passages 52 and 54 is decreased.This results in the portions 32 and 34 of the suture 36 being firmlyclamped between the gripper surface areas 78 and 80 on the lower section46 and the gripper surface areas 82 and 84 on the upper section 48 ofthe retainer 30. The force applied to the portions 32 and 34 of thesuture 36 by the gripper surface areas 78, 80, 82 and 84 on the lowerand upper sections 46 and 48 of the retainer 30 is effective to deformthe suture from the circular cross sectional configuration illustratedin FIG. 7 to a generally oval cross sectional configuration illustratedschematically in FIG. 8. Although the illustrated suture 36 is amonofilament, it is contemplated that the suture could be formed by aplurality of filaments which are braided or twisted together.

The energy which is applied to the retainer 30 by the member 144 may bethermal energy, vibratory energy, or light energy. The energy may betransmitted by radio frequency waves, ultrasonic waves, heat waves, orlight waves. The energy may be vibratory ultrasonic or radio frequencyenergy. Rather than positioning the member 140 in the groove 142 in thelower section 46 of the retainer 30, the groove 142 may be omitted and aflat member, similar to the member 144, may be pressed against the lowersection 46 of the retainer 30. Energy may be transmitted to the retainerthrough either the member 140 or the member 144 or both of the members140 and 144.

In the embodiment of the invention illustrated in FIG. 8, the portions32 and 34 of the suture 36 are clamped between the lower section 46 andupper section 48 of the retainer 30. The clamping force applied againstthe portions 32 and 34 of the suture 36 by the retainer 30, holds theretainer and the portions of the suture against relative movement. Thisresults in the suture 36 and retainer 30 being securely interconnected.

There is some bonding of material of the retainer to the portions 32 and34 of the suture 36 to further interconnect suture and the retainer.However, the amount of force and energy transmitted from the member 140or both of the members 140 and 144 to the retainer 30 is sufficient toeffect a plastic deformation of the material of the retainer withoutexcessive plastic deformation of the material of the suture 36. Byavoiding excessive deformation of the material of the suture 36,weakening of the suture is avoided. Thus, once the plastic deformationof the retainer 30 has been effected by the transmission of force andenergy to the retainer, the lower and upper sections 46 and 48 of theretainer are fixedly interconnected with the suture 36 withoutsignificantly weakening of the suture.

The end portions 124 and 126 of the projections 66 and 68 have a pointedconfiguration. Thus, the end portion 124 of the projection 66 includes aflat side surface area 150 which intersects a flat side surface area 152at a linear point or peak. Therefore, there is line contact between theend portion 124 of the right projection 66 and the flat bottom surface118 of the right recess 58. Similarly, the end portion 126 of the leftprojection 68 has a flat side surface 156 which intersects a flat sidesurface 158 at a linear point or peak on the end portion 126 of the leftprojection 68. This results in line contact between the pointed endportion of the left projection 68 and the flat bottom surface 120 of theleft recess 60. However, the end portions 124 and 126 of the projections66 and 68 may have a conical configuration if desired.

By forming the end portions 124 and 126 of the right and leftprojections 66 and 68 with a pointed configuration, the end portions ofthe projections are effective to function as energy directors forultrasonic vibratory energy. The pointed end portions 124 and 126 of theright and left projections 66 and 68 are effective to direct ultrasonicvibratory energy transmitted from the member 144 to the ends of theprojections and to the bottom surfaces 118 and 120 of the recesses 58and 60. The pointed configuration of the end portions 124 and 126 of theprojections 66 and 68 concentrates the energy and facilitates melting ofthe material of the projections. To a lesser extent, the material of thelower section 46 of the retainer 30 is melted adjacent to the bottomsurfaces 118 and 120. This results in a secure bonding andinterconnection between the lower and upper sections 46 and 48 of theretainer 30.

Applicator Assembly

An improved applicator assembly 172 (FIGS. 9-12) is utilized to grip theretainer 30 with a constant predetermined force, to move the retainer 30along the suture 36 to a desired position relative to the body tissue40, and to transmit energy to the retainer 30. The applicator assembly172 may be used to perform any one or more of foregoing functions ratherthan all of the functions.

The applicator assembly 172 includes a rigid energy transmission member174 (FIG. 9) which corresponds to the member 144 in FIG. 8. A rigidtubular force transmitting member 176 extends around and is coaxial withthe cylindrical energy transmission member 174. The cylindrical forcetransmitting member 176 corresponds to the member 140 in FIG. 8.

A biasing assembly 178 continuously urges the force transmitting member176 toward the left (as viewed in FIG. 9) with a constant predeterminedforce. The illustrated embodiment of the biasing assembly 178 includes ahelical spring 180 which is disposed between an annular flange 182 on areaction member 184 and an annular piston 186. The annular piston 186 isfixedly connected to a housing 188. The housing 188 is connected to thetubular force transmitting member 176. The reaction member 184 isfixedly connected to a manually engagable handle 194.

A trigger 198 is pivotally connected with the handle 194. The trigger198 is manually pivotal in a clockwise direction (as viewed in FIGS. 9and 11). Clockwise pivotal movement of the trigger 198 transmits forcethrough a yoke 200. The force transmitted through the yoke 200 moves thehousing 188 toward the right (as viewed in FIGS. 9 and 11). Thisrightward movement of the housing 188 moves a flange 204 on the right(as viewed in FIGS. 9 and 12) or distal end of the tubular forcetransmitting member 176 away from a circular end surface 206 on theenergy transmission member 174.

The rightward (as viewed in FIGS. 9 and 12) movement of the forcetransmitting member 176 relative to the energy transmission member 174increases space between the flange 204 and end surface 206 on the energytransmission member 174. Increasing the space between the flange 204 andthe end surface 206 enables the retainer 30 to be positioned between theflange 204 and the end surface 206 with the portions 32 and 34 of thesuture 36 extending through the passages 52 and 54 in the retainer 30 inthe manner illustrated in FIG. 7.

When the retainer 30 is positioned in the gap between the end surface206 (FIGS. 9 and 12) on the energy transmission member 174 and theflange 204 connected with the force transmitting member 176, the flange204 is positioned in the groove 142 in the retainer 30 in the samemanner as in which the member 140 is illustrated as engaging the groove142 in FIG. 8. The end surface 206 (FIGS. 9 and 12) on the energytransmission member 174 is disposed in engagement with the surface 146on the upper section 48 of the retainer 30 in the same manner as inwhich the member 144 (FIG. 8) engages the surface 146.

Once the retainer 30 has been positioned in the space between the flange204 and the end surface 206 on the energy transmission member 174 (FIGS.9 and 12), the trigger 198 is released. When the trigger 198 isreleased, the biasing spring 180 is effected to urge the housing 188toward the left (as viewed in FIGS. 9 and 11). The leftward forceapplied by the spring 180 against the housing 188 is transmitted throughthe force transmitting member 176 and flange 204 to the retainer 30.This results in the retainer 30 being clamped between the flange 204 onthe force transmitting member 176 and end surface 206 on the energytransmission member 174. The spring 180 is effective to apply a constantpredetermined biasing force to the piston ring 186. This constantbiasing force is transmitted through the housing 188 and forcetransmitting member 176 to the retainer 30.

Prior to the transmission of energy to the retainer 30 through theenergy transmission member 174, the force applied against the retainer30 is ineffective to cause significant plastic deformation of thematerial of the retainer 30. At this time, the end portions 124 and 126(FIG. 7) of the right and left projections 66 and 68 are pressed againstthe bottom surfaces 118 and 120 of the recesses 58 and 60 with aconstant force. The portions 32 and 34 of the suture 36 are freelymovable in the passages 52 and 54.

While the retainer 30 is gripped with a predetermined constant force bythe applicator assembly 172, the retainer is moved to a desired positionrelative to the body tissue 40. To position the retainer 30 relative tothe body tissue, the surgeon holds the handle 194 of the applicatorassembly 172 in one hand and tensions the portions 32 and 34 of thesuture 36 with the other hand. The surgeon then manually applies forceagainst the handle 194 to slide the retainer 30 along the tensionedportions 32 and 34 of the suture 36 toward the body tissue 40. Therelatively long force transmitting member 176 and energy transmittingmember 174 enable the applicator assembly 172 to move the retainer 30through a small incision to a remote location in a patient's body as theretainer slides along the suture 36.

During performance of a surgical procedure, the suture 36 may be movedthrough a cannula to a location disposed within a patient's body. Thesuture 36 is then positioned relative to the tissue 40 at the remotelocation in the patient's body. However, it should be understood thatthe cannula may be omitted and the suture 36 moved through an openincision.

Once the suture 36 has been moved to the desired location relative tothe tissue 40 in the patient's body, the portions 32 and 34 of thesuture may be positioned in the passages 52 and 54 through the retainerwhile the retainer is disposed outside of the patient's body. Once theportions 32 and 34 of the suture 36 have been positioned in the passages52 and 54 to the retainer 30, the retainer is gripped by the applicatorassembly 172. The flange 204 on the force transmitting member 176 andend surface 206 on the energy transmission member 174 of the applicatorassembly 172 are effective to apply a predetermined constant forceagainst opposite sides of the retainer 30 to securely grip the retainerwith the applicator assembly 172.

While the retainer is gripped by the applicator assembly 172, the endportions 32 and 34 of the suture are manually tensioned and the retaineris slid along the portions 32 and 34 of the suture toward the bodytissue. As the retainer 30 is slid along the suture 36 toward the bodytissue 40, the applicator assembly 172 moves the retainer into thepatient's body. As the retainer 30 is moved into the patient's body, itis gripped with a constant predetermined force by the applicatorassembly 172.

Alternatively, the retainer 30 may be gripped by the applicator assembly172 outside of the patient's body prior to insertion of the portions 32and 34 of the suture through the passages 52 and 54. The portions 32 and34 of the suture 36 may then be inserted through the passages 52 and 54in the retainer 30 while the retainer is gripped by the applicatorassembly 172. If desired, insertion of the portions 32 and 34 of thesuture 36 through the passages 52 and 54 in the retainer 30 may beperformed with the retainer inside the patient's body.

If the applicator assembly 172 is utilized to move the retainer 30through a cannula into the patient's body before the suture 36 isinserted into the passages 52 and 54 through the retainer, suitableinstruments may be utilized to grip the portions 32 and 34 of the suturein the patient's body and to move the portions 32 and 34 of the suturethrough the passages 52 and 54. The instruments which engage the sutureand move it through the passages 52 and 54 while the retainer 40 isgripped by the applicator assembly 172, may extend through the cannulaalong with the applicator assembly. Alternatively, the instruments whichmove the portions 32 and 34 of the suture 36 through the passages 52 and54 may be moved into the patient's body through a cannula spaced fromthe cannula through which the applicator assembly 172 moves the retainerinto the patient's body. In order to minimize incisions in the patient'sbody, it may be preferred to utilize a single cannula to accommodatemovement of the applicator assembly 172, retainer 30, suture positioninginstruments, and the suture 36 into the patient's body.

It is contemplated that it may be desired to position the suture 36 andretainer 30 in a patient's body with a robotic mechanism. When this isto be done, the manually engagable handle 194 and trigger 198 on theapplicator assembly 172 may be eliminated. The remainder of theapplicator assembly may then be connected with the robotic mechanism. Asuitable motor may be provided in the robotic mechanism to move theforce transmitting member 176 against the influence of the biasingspring 180. Even though the handle 194 and trigger 198 are eliminated,the retainer 30 would be gripped between the flange 204 on the forcetransmitting member 176 and end surface 206 on the energy transmissionmember 174 with a constant force.

The robotic mechanism with which the applicator assembly 172 isconnected may have a plurality of adaptive arms which are effective tomove the retainer 30 and other instruments in a patient's body. Therobotic mechanism may be a reprogrammable, multifunctional manipulatordesigned to move through various program motions for the performance ofselected one of a plurality of surgical procedures. The roboticmechanism may have manually operable controls which provide forinteraction between a surgeon and the robotic mechanism. The roboticmechanism may have any one of many different constructions and may beoperated in any one of many different manners, including those disclosedin U.S. patent application Ser. No. 10/102,413 filed Mar. 20, 2002 byPeter M. Bonutti and entitled Methods of Securing Body Tissue.

When the applicator assembly 172 is to be utilized in association with arobotic mechanism, it is believed that it may be desired to utilize amonitor or display in association with the robotic mechanism. A singleimaging device or a plurality of imaging devices may be used. If aplurality of imaging devices are used, it is contemplated thatstereoscopic and/or video stereoscopic viewing at a location where asurgical procedure is being performed may be accommodated by the imagingapparatus. The imaging apparatus may include a plurality of endoscopes.

A navigation system may be utilized to provide inputs to the computer toassist in the control of the robotic mechanism and the performance of asurgical procedure. The navigation system may be an optical navigationsystem in which end portions of navigation members are illuminated bylight. The navigation members may be connected with one or more tissuesin a patient's body. The tissue with which the navigation members areconnected may either bone or soft tissue.

It is also contemplated that imaging devices such as a fluoroscope,and/or magnetic resonance imaging unit and/or ultrasonic imaging unitmay be utilized with the robotic mechanism. If desired, endoscopes maybe utilized in association with the various imaging units. The imagingunits and robotic mechanisms may have a construction and cooperate witheach other in the same manner as described in the aforementioned U.S.patent application Ser. No. 10/102,413 filed Mar. 20, 2002 by Peter M.Bonutti.

Once the retainer 30 has been positioned in a desired relationship withbody tissue 40 and the suture 36, the portions 32 and 34 of the suture36 are pulled with a predetermined force. This results in apredetermined tension being established in the portions 32 and 34 of thesuture 36. While the predetermined tension is maintained in the suture36, the retainer 30 is plastically deformed to connect the retainer withthe portions 32 and 34 of the suture 36 and hold the portions 32 and 34of the suture against movement relative to each other and the retainer30. To effect plastic deformation of the retainer 30 and connection ofthe retainer with the suture 36, energy is transmitted from an energysource 212 (FIG. 9) through the energy transmission member 174 to theretainer 30. At this time, the retainer 30 is clamped between the flange204 on the force transmitting member 176 and the end surface 206 on theenergy transmission member 174.

In the illustrated embodiment of the applicator assembly 172, the energysource 212 is a source of ultrasonic vibratory energy at a frequencyabove that which can normally be detected by the human ear, that isabout 16 to 20 kilohertz. Although there are a wide range of frequencieswhich may be utilized, it is believed that it may be desirable to useultrasonic energy having a frequency of between 20 kilohertz and 70kilohertz. It is believed that it may be desired to use ultrasonicvibratory energy of a frequency between 39.5 and 41 kilohertz. When afoot pedal actuated switch 214 (FIG. 9) is closed, ultrasonic vibratoryenergy is transmitted through the energy transmission member 174 to theretainer 30. The ultrasonic vibratory energy creates frictional heat atthe pointed end portions 124 and 126 of the projections 66 and 68. Thefrictional heat provided by the ultrasonic vibratory energy is effectiveto heat material of the suture retainer 30 into its transitiontemperature range while the material of the suture 36 remains at atemperature below its transition temperature range. For example, thesuture 36 may be formed of a material having a transition temperaturerange which is above 190 degrees Celsius. The suture retainer 40 mayhave a transition temperature range which begins at a temperature below190 degrees Celsius.

However, it should be understood that even the entire transitiontemperature range for the suture 36 could be co-extensive with thetransition temperature range for the retainer 30. In fact, thetransition temperature range of the suture 36 could extend below thetransition temperature range of the retainer 30. However, it is believedthat it may be preferred to have the transition temperature range forthe suture 36 above at least a portion of the transition temperaturerange of the retainer 30.

Ultrasonic vibratory energy is transmitted from the energy transmissionmember 174 to the upper section 48 of the retainer 30. The right andleft projections 66 and 68 (FIG. 7) from the upper section 48 of theretainer 30 function as energy directors which direct the ultrasonicvibratory energy to the locations where the end portions 124 and 126 ofthe projections 66 and 68 engage the bottom surfaces 118 and 120 of therecesses 58 and 60 in the lower section 46 of the retainer 30. Thepointed end portions 124 and 126 of the projections 66 and 68concentrate the vibratory energy transmitted through the energytransmission member 174 at the locations where the projections engagethe bottom surfaces 118 and 120 of the recesses 58 and 60.

The ultrasonic vibratory energy is effective to soften and make thematerial forming the end portions 124 and 126 of the projections 66 and68 flowable under the influence of the constant predetermined forcetransmitted from the biasing spring 180 through the force transmissionmember 176 and flange 204 to the lower section 46 of the retainer 30. Asthe temperature of the end portions 124 and 126 of the projections 66and 68 increases, the lower section 46 of the retainer 30 moves towardthe upper section 48 of the retainer. This results in material whichoriginally formed the pointed end portions 124 and 126 of theprojections 66 and 68 being deflected sideways in the lower (as viewedin FIG. 7) portions of the recesses 58 and 60.

The continued application of a constant clamping force to the retainer30 and the transmission of vibratory energy to the retainer causes theend surface 130 on the center projection 72 to move into engagement withthe circular body 64 of the upper section 48. There may be a limitedheating, melting and deformation of the center projection 72 as a resultof engagement of the center projection with the upper section 48.

Although it is believed that it will be preferred to apply ultrasonicvibratory energy to the retainer 30, other forms of energy may beapplied to the retainer if desired. For example, thermal or light(laser) energy may be applied to the retainer if desired. The energyapplication apparatus may be separate from the apparatus which is usedto position the retainer relative to the body tissue 40 and suture 36.Thus, the retainer 30 may be positioned relative to body tissue 40 andthe suture 36 manually or by using a first apparatus. Energy may then beapplied to the retainer 30 using a second apparatus.

The heated, flowable material of the end portions 124 and 126 of theprojections 66 and 68 may flow along the side surfaces 102, 104, 110 and112 of the recesses 58 and 60. Some of the material of the end portions124 and 126 of the projections 66 and 68 may engage and bond to theportions 32 and 34 of the suture 36.

At the same time, the portions 32 and 34 of the suture 36 are deflectedfrom their original circular configuration (FIG. 7) to an ovalconfiguration under the influence of force applied against the portionsof the suture disposed between the lower section 46 and upper section 48of the retainer 30. Although the portions 32 and 34 of the suture 36 areresiliently deflected to the configuration illustrated schematically inFIG. 8, there is minimal bonding of the material with the retainer 30 tothe suture 36 and no significant loss of strength of the suture. Due tothe clamping action between the flange 204 and end surface 206 on theenergy transmission member 174 (FIG. 9) against the retainer 30, theoverall height of the retainer is decreased. At the same time, theoverall diameter of the retainer increases.

When the transmission of ultrasonic vibratory energy through the energytransmission member 174 is interrupted, the material of the retainer 30cools and there is an ultrasonic welding of the lower section 46 of theretainer to the upper section 48 of the retainer. The bonding betweenthe lower section 46 and upper section 48 of the retainer 30 occursmainly between the projections 66 and 68 and the lower section 48 of theretainer. There may be some bonding of the center projection 130 to thecircular body 64 of the upper section 48 of the retainer. In addition,there may be some bonding material of the lower section 46 and uppersection 48 of the retainer to the portions 32 and 34 of the suture 36.

The portions 32 and 34 of the suture 36 are held against movementrelative to each other and to the retainer primarily 30 by a clampingaction between surfaces on the lower section 46 and surfaces on theupper section 48 of the retainer. Thus, the portions 32 and 34 of thesuture 36 are securely gripped between the gripper surface areas 78 and80 on the lower section 46 of the retainer 30 and the gripper surfaceareas 82 and 84 on the upper section 48 of the retainer 30. By holdingthe portions 32 and 34 of the suture 36 against movement relative toeach other and to the retainer 30 with a clamping action, there isminimal deformation of the suture and the strength of the suture is notimpaired.

Although one specific preferred embodiment of the applicator assembly172 has been illustrated in FIGS. 10-12, it is contemplated that theapplicator assembly could have a different construction and/or mode ofoperation. For example, the applicator assembly 172 may have any one ofthe constructions and mode of operations disclosed in U.S. patentapplication Ser. No. 10/076,919 filed Feb. 15, 2002 by Peter M. Bonutti,et al and entitled Method of Using Ultrasonic Vibration to Secure BodyTissue. Although it is believed that a retainer having a constructionsimilar to that illustrated in FIGS. 1-8 may be preferred, it iscontemplated that the applicator assembly 172 of FIGS. 9-12 may beutilized with retainers having a different construction. For example,the applicator assembly 172 may be utilized in association with aretainer having any one of the constructions disclosed in theaforementioned U.S. patent application Ser. No. 10/076,919 filed Feb.15, 2002 by Peter M. Bonutti or any one of the constructions disclosedin U.S. Pat. No. 6,010,525.

The leading end portion of the force transmitting member 176 (FIG. 12)extends part way around the end surface 206 on the energy transmissionmember 174. This results in the formation of a shield 220 which extendspart way around the retainer 30 when the retainer 30 is clamped betweenthe flange 204 and the end surface 206 on the energy transmission member174. The shield 220 has an inner side surface 222 which forms a portionof a cylinder. The side surface 222 engages the cylindrical periphery ofthe retainer 30 to position the retainer relative to the energytransmission member 174 in a direction transverse to a longitudinalcentral axis of the energy transmission member.

The shield 220 is effective to at least partially block engagement ofbody tissue with the retainer 30 as the retainer is positioned in apatient's body and as energy is transmitted to the retainer from theenergy transmission member 174. It is contemplated that the shield 220could be constructed in such a manner as to extend completely around theretainer 30. This would allow use of the applicator assembly 172 in amoist environment or in an aqueous environment in which the retainer iscompletely or almost completely submerged in liquid.

The force transmitting member 176 has a flange 204 which engages thegroove 142 in the same manner as which the member 140 is schematicallydepicted as engaging a groove 142 in FIG. 8. However, it is contemplatedthat the flange 204 could be eliminated and a circular end plateprovided at the distal end of the force transmitting member 176. The useof a plate would provide for a wider area of engagement of the forcetransmitting member 176 with the lower section 46 of the retainer 30.The use of a circular end plate in place of the flange 204 would allowthe groove 142 in the lower section 46 of the retainer to be eliminated.

Prior to connecting the retainer 30 with the suture 36, the portions 32and 34 of the suture are pulled with a predetermined tension. Tensioningthe suture with a predetermined force may be accomplished in the mannerdisclosed in the aforementioned U.S. patent application Ser. No.09/556,458 filed May 3, 2000 by Peter M. Bonutti and entitled Method andApparatus For Securing Tissue or in the manner disclosed in U.S. patentapplication Ser. No. 10/102,413 filed Mar. 20, 2002 by Peter M. Bonuttiand entitled Methods of Securing Body Tissue. Once a desired tension hasbeen established in the intermediate portion 38 (FIG. 1) of the suture36, the applicator assembly 172 is utilized to interconnect the lowersection 46 and upper section 48 of the retainer in the manner previouslydiscussed.

Since the portions 32 and 34 of the suture 36 were positioned in thepassages 52 and 54 on opposite sides of the center projection 72, theportion 32 of the suture applies force against the lower section 46 ofthe retainer on the right (as viewed in FIG. 7) side of the central axisof the retainer. The portion 34 of the suture applies force against thelower section 46 of the retainer on the left side of the centerprojection 72. This results in the application of offsetting movementsto the lower section 46 of the retainer. Therefore, the retainer 30 doesnot tend to rotate on an axis disposed between the portions 32 and 34 ofthe suture 36 and is stable relative to the body tissue 40.

Although it is believed that it may be desired to use the applicatorassembly 172 to position the retainer 30 relative to body tissue, itshould be understood that other ways of positioning the retainer elativeto body tissue may be utilized. For example, a surgeon may grasp theretainer 30 with one hand and tension the portions 32 and 34 of thesuture 36 with the other hand. The surgeon would then manually applyforce against the retainer 30 to slide the retainer along the tensionedportions 32 and 34 of the suture toward the body tissue. Rather thangripping the retainer 30 with one hand, the surgeon may grip theretainer 30 with a manually actuated instrument.

If the retainer 30 is manually positioned relative to body tissue orpositioned with a manually actuated instrument, a source of energy willhave to be provided to interconnect the sections 46 and 48 of theretainer. The energy source may have any of the constructions disclosedin U.S. Pat. No. 6,368,343. Alternatively, the energy source may havethe construction disclosed in U.S. Pat. No. 3,513,848.

Looped Suture

In FIGS. 1-8, the portions 34 and 36 of the suture extend straightthrough the retainer 30 in a generally parallel relationship with eachother. However, it is contemplated that the portions 34 and 36 of thesuture may be looped around portions of the retainer to increase thestrength of the connection between the suture 36 and the retainer 30. Inthe embodiment of FIG. 13, the suture is looped around the projections66 and 68 from the upper section 48 of the retainer. By looping theportions 32 and 34 of the suture around the projections 66 and 68, inthe manner illustrated in FIG. 13, the strength of the grip which theretainer 30 obtains on the suture is increased.

When the suture 36 is to be positioned relative to the retainer 30 andlooped around the projections 66 and 68, in the manner illustratedschematically in FIG. 13, the portion 32 of the suture is insertedthrough the passage 52 between the right projection 66 from the uppersection 48 of the retainer. The portion 32 of the suture is then wrappedaround the projection 66 and again inserted through the passage 52 toform a loop around the projection 66. The portion 34 of the suture 36 islooped around the projection 68 from the upper section 48 of theretainer 30 in the same manner as in which the portion 32 of the sutureis looped around the projection 66.

As was previously mentioned, the portions 32 and 34 of the suture 36 aremoved in opposite directions into the retainer 30. Thus, when theportion 32 of the suture 36 is initially moved through the passage 52,the suture is moved downward (as viewed in FIG. 13) through the passageand then wrapped upwardly around the projection 66 in a counterclockwise direction (as viewed in FIG. 13) and again moved downwardthrough the passage 52. When the portion 34 of the suture is to bepositioned in the passage 54 in the retainer 30, the portion 34 of thesuture is first moved upward (as viewed in FIG. 13) through the passage54 and then wrapped in a counter clockwise direction about theprojection 68. As the portion 34 of the suture is wrapped around theprojection 68, the portion 34 of the suture is again inserted throughthe passage 54. This results in the formation of a loop 232 around theprojection 68. The intermediate portion 38 of the suture 36 extendsupward (as viewed in FIG. 13) from the loop 230 and extends downward (asviewed in FIG. 13) from the loop 232.

Once the loops 230 and 232 have been formed in the portions 32 and 34 ofthe suture 36, the retainer 30 is gripped by the applicator assembly 172and moved along the suture 36 toward the body tissue in the mannerpreviously discussed. Movement of the retainer along the suture 36toward the body tissue will, to some extent, be impeded by the loops 230and 232 in the suture 36. By applying force with a handle 194 of theapplicator assembly 172, the retainer 30 can be moved along the suture36 toward the body tissue after the loops 230 and 232 have been formedin the suture 36. It should be understood that the retainer 30 may bemanually moved along the suture 36 or moved along the suture with anapplicator assembly having a construction which is different than theconstruction of the applicator assembly 172.

Although the loops 230 and 232 have been illustrated as being formedaround the projections 66 and 68 from the upper section 48 of theretainer 30, it is contemplated that the loops could be formed around adifferent portion of the retainer 30 if desired. For example, one orboth of the loops 230 and 232 could be formed around the centerprojection 72.

Alternatively, both of the loops 230 and 232 could be formed around bothof the projections 66 and 68. When this is to be done, the portion 32 ofthe suture 36 would be moved downward (as viewed in FIG. 13) through thepassage 52 and looped around the outside of the projection 66 across theupper (as viewed in FIG. 13) end portion of the center projection 72 anddownward around the left projection 68, across the bottom (as viewed inFIG. 13) of the center projection 72 and again wrapped around theoutside of the right projection 66. The portion 32 of the suture 36would then be moved downward for a second time, through the passage 52.Similarly, the portion 34 of the suture 36 is moved upward (as viewed inFIG. 13) through the passage 54, downward around the left projection 68,across the lower (as viewed in FIG. 13) end of the center projection 72upward around the outside of the right projection 66. The loop wouldthen be moved across the upper end portion of the center projection 72and downward (as viewed in FIG. 13) for a second time across the outsideof the left projection 68. The portion 34 of the suture 36 would thenagain be moved upward through the passage 54.

Embodiment of FIGS. 14-16

In the embodiment of the retainer illustrated in FIGS. 1-8, the retainer30 has a center projection 72 which cooperates with the right and leftprojections 66 and 68 to form the two elongated passages through whichthe portions 32 and 34 of the suture are moved in opposite directions.In the embodiment of the invention illustrated in FIGS. 14-16, thecenter projection on the retainer is omitted. Since the embodiment ofthe invention illustrated in FIGS. 14-16 is generally similar to theembodiment of the invention illustrated in FIGS. 1-8, similar numeralswill be utilized to identify similar components, the suffix “a” beingassociated with the numerals of FIGS. 14-16 to avoid confusion.

A retainer 30 a includes a lower section 46 a and an upper section 48 a.The lower section 46 a has a pair of recesses 58 a and 60 a. Therecesses 58 a and 60 a have the configuration as the recesses 58 and 60of FIGS. 1-8. Right and left projections 66 a and 68 a extend downward(as viewed in FIG. 14) from the upper section 48 a into the recesses 58a and 60 a in the lower section 60 a. There is an interference fitbetween the projections 66 a and 68 a and the recesses 58 a and 60 a tohold the upper section 48 a in a desired spatial relationship with thelower section 46 a of the retainer 30 a. In the embodiment of theinvention illustrated in FIG. 15, the portions 32 a and 34 a of thesuture 36 a are disposed in a side-by-side relationship in a singlepassage 240 (FIG. 14) which extends between projections 66 a and 68 afrom the portion 48 a of the retainer 30 a.

When the retainer 30 a is gripped by the applicator assembly 172 with aconstant predetermined force, end portions 124 a and 126 a (FIG. 14) ofthe projections 66 a and 68 a are pressed against bottom surfaces of therecesses 58 a and 60 a in the manner previously described in conjunctionwith the embodiment of the invention illustrated in FIGS. 1-8. Theprojections 66 a and 68 a have the same configuration as the projections66 and 68 of FIGS. 3-7. Therefore, there is line contact between thetapered end portions 124 a and 126 a of the projections 66 a and 68 aand the flat bottom surfaces of the recesses 58 a and 60 a.

The portions 32 a and 34 a of the suture 36 a are inserted in oppositedirections through the passage 240 formed between the lower section 46 aand upper section 48 a of the retainer 30 a. The retainer 30 a is slidalong the suture 36 a to a desired position relative to body tissuewhile the retainer is gripped with a constant predetermined force by theapplicator assembly 172. If desired, the retainer 30 a may be manuallygripped and slid along the portions 32 a and 34 a of the suture 36 a.

If the retainer 30 a is manually positioned relative to body tissue, asuitable source of energy will have to be provided to effect heating ofthe retainer. This source of energy may have any one of theconstructions disclosed in U.S. Pat. Nos. 3,513,848 and 6,368,343.Alternatively, the source of energy may have a known construction and bea source of thermal in light (laser) energy.

Assuming that the applicator assembly 172 is utilized to position theretainer 30, when the foot pedal actuated switch 214 (FIG. 9) is closed,ultrasonic vibratory energy is transmitted from the source 212 throughthe energy transmission member 174 to the retainer 30 a (FIG. 14). Thetapered end portions 124 a and 126 a of the projections 66 a and 68 afunction as energy directors and concentrate the ultrasonic vibratoryenergy from the source 212. As this occurs, the end portions 124 a and126 a of the projections 66 a and 68 a are softened and deformed underthe influence of the constant predetermined force applied against theretainer 30 a by the applicator assembly 172 As this occurs, thedistance between the lower section 46 a and upper section 48 a isdecreased and the portions 32 a and 34 a of the suture 36 a are grippedbetween flat gripper surfaces 242 and 244 formed on the upper section 48a and lower section 46 a of the retainer 30 a.

In FIG. 15, the portions 32 a and 34 a of the suture 36 a extendstraight through the passage in opposite directions. In the embodimentillustrated in FIG. 16, the portions 32 a and 34 a of the suture arelooped around the projections 66 a and 68 a in the same manner aspreviously described in conjunction with FIG. 13. This results in theformation of loops 230 a and 232 a around the projections 66 a and 68 a.By wrapping the portions 32 a and 34 a of the suture 36 a around theprojections 66 a and 68 a, the portions 32 a and 34 a are positioned inthe passage 240 at locations equal distances from the center of theretainer 30 a. This minimizes any movement resulting from forces appliedto the retainer 30 a by the suture 36 a and increases the stability ofthe retainer on the body tissue.

In the embodiment of the invention illustrated in FIGS. 1-8 and 14-16,the lower section 46 is provided with recesses 58 and 60. However, it iscontemplated that the recesses 58 and 60 may be omitted if desired. Ifthe recesses 58 and 60 are omitted, the projections 66 and 68 (FIGS. 7and 8) will engage a flat upper side surface on the base section 46.With this construction, the pointed end portions 124 a and 126 a (FIG.14) of the projections 66 a and 68 a will engage a flat surface 244 onthe base section 46 a.

When the recesses 58 and 60 are omitted, it may be desired to provideother structure to maintain the lower and upper sections 46 and 48 ofthe retainer in a desired spatial relationship during insertion of thesuture 36 into a passage 24 or passages 52 and 54. For example, thecenter projection 72 (FIG. 3) may extend into an opening through theupper section 48. An interference fit may be provided between the centerprojection and the opening in the upper section 48. Alternatively, aguide surface connected with the lower section 46 of the retainer mayengage a guide surface on the upper section 48.

Embodiment of FIG. 17

In the embodiments of the invention illustrated in FIGS. 1-8 and 14-16,a plurality of projections from the upper section 48 engage recesses inthe lower section 46. In the embodiment of the illustrated in FIG. 17, asingle projection from the upper section engages an upper side of thelower section. Since the embodiment of the invention illustrated in FIG.17 is generally similar to the embodiments of the invention illustratedin FIGS. 1-8 and 14-16, similar numerals will be utilized to identifysimilar components, the suffix letter “b” being added to the numerals ofFIG. 17 to avoid confusion.

A retainer 30 b includes a lower or base section 46 b and an upper orcover section 48 b. A right passage 250 and a left passage 252 areformed in the lower section 46 b. Similarly, a right passage 256 and aleft passage 258 are formed in the upper section 48 b. A suture 36 bextends through the passages 250, 252, 256 and 258 in the lower andupper sections 46 b and 48 b of the retainer 30 b. The suture 36 bincludes end portions 32 b and 34 b which are interconnected by anintermediate portion 38 b. The intermediate portion 38 b of the suture36 b extends around body tissue in much the same manner as isillustrated schematically in FIG. 1 for the suture 36.

A single projection 262 extends from the upper section 48 b of theretainer 30 b. The projection 262 is offset to one side of the suture 36b. The projection 262 has a pointed end portion 264 which is engagablewith a flat upper side surface 266 on the lower portion 46 b of theretainer 30 b. The pointed end portion 264 of the projection 262 has thesame general configuration as the pointed end portions 124 and 126 ofthe projections 66 and 68 in FIG. 7. However, the pointed end portion264 of the projection 262 may have a conical configuration if desired.

If desired, a pair of projections, corresponding to the projections 66and 68, may be provided. If this is done, one of the projections wouldbe offset from the suture 36 b in a direction into the page on whichFIG. 17 is disposed and the other projection would be offset from thesuture 36 b in a direction out of the page on which FIG. 17 is disposed.This would result in a passage being formed between the two projectionsso that the portions 32 b and 34 b of the suture 36 b would both extendthrough a passage between the projections.

When the suture 36 b and retainer 30 b are to be connected with bodytissue, the suture may be positioned relative to the body tissue in themanner previously described in conjunction with in the embodiment of theinvention illustrated in FIGS. 1-8. As was previously mentioned, thismay be done using minimally invasive surgical techniques. The suture 36b may be moved into a patient's body through a cannula and positionedrelative to tissue in the patient's body. The end portions 32 b and 34 bof the suture may extend through the cannula and be accessible to asurgeon.

The portion 32 b of the suture 36 b is inserted through the nonlinearpassage 250 in the lower section 46 b and through the nonlinear passage258 in the upper section 48 b of the retainer 30 b. The portion 34 b ofthe suture is inserted through the nonlinear passage 252 in the lowerportion 46 b and through the nonlinear passage 256 in the upper portion48 b, in the manner indicated schematically in FIG. 17. The lowersection 46 b and upper section 48 b are then gripped by an applicatorassembly which may have the same construction as the applicator assembly172 of FIGS. 9-12.

While the retainer 30 b is gripped with a constant predetermined forceby the applicator assembly 172, the surgeon grips the applicatorassembly with one hand and the portions 32 b and 34 b of the suture 36 bwith the other hand. The retainer 30 b is then slid along the suture 36b toward the body tissue around which the intermediate portion 38 b ofthe suture extends. As this occurs, the end portion (FIG. 12) of theapplicator assembly 172 moves through the cannula and slides theretainer 30 b along the suture 36 b to a position that is engagementwith the body tissue, that is, to a position similar to that in FIG. 1for the retainer 30. While the retainer 30 b is being slid along thesuture 36 b, the applicator assembly grips the retainer with a constantpredetermined force.

If desired, the retainer 30 b may be positioned relative to the suture36 b and body tissue in a way other than use of the applicator assembly172. For example, the retainer 30 b may be gripped by one hand of asurgeon and the portions 32 b and 34 b of the suture gripped andtensioned with the other hand. The manual application of force to theretainer 30 b would slide the retainer along the suture 36 b.

Once the retainer 30 b has been positioned relative to the body tissueand the suture 36 b is tensioned with a desired force, energy isconducted from a source of energy, similar to the energy source 212 ofFIG. 9, to the energy transmission member 174 and the retainer 30 b. Itis contemplated that many different types of energy could be transmittedto the retainer 30 b. For example, radio frequency, ultrasonic, heat, orlight energy may be transmitted to the retainer 30 b through an energytransmission member. In the embodiment of the applicator assembly 172illustrated in FIGS. 9-12, ultrasonic vibratory energy is conducted tothe retainer 30 b through the energy transmission member 174 while theapplicator assembly 172 grips the retainer 30 b with a constantpredetermined force.

The projection 262 functions as an energy director which concentratesenergy applied to the upper section 48 of the retainer 30 b by the endsurface 206 of the energy transmission member 174 (FIG. 9). Theconcentrated ultrasonic vibratory energy transmitted from the energytransmission member 174 heats the material of the projection 262 (FIG.17) and the material of the base section 46 b engaged by the projectioninto its transition temperature range. As this occurs, there is asoftening and deforming of the material of the projection 262.

A flat lower side surface 270 on the upper portion 48 b of the retainer30 b and the flat upper side surface 266 of the lower portion 46 b ofthe retainer move into engagement with each other. Material of theretainer 30 b tends to flow into the passages 250, 252, 256 and 258formed in the lower and upper sections 46 b and 48 b of the retainer 30b. The portions 32 b and 34 b of the suture 36 b are firmly clampedbetween the side surfaces 266 and 270 on the lower section 46 b andupper section 48 b of the retainer 30 b.

As the material of the retainer 30 b cools and the applicator assembly172 is disengaged from the retainer, there may be a limited amount ofbonding of the material of the retainer 30 b to the portions 32 b and 34b of the suture 36 b. Although the suture 36 b is, to some extent,deformed by force transmitted between the side surfaces 266 and 270 onthe lower section 46 b and upper section 48 of the retainer 30 b, in themanner illustrated schematically in FIG. 8 for the suture 36, thedeformation of the suture does not weaken the suture.

It is contemplated that the sections 46 b and 48 b of the retainer 30 bmay be made of many different polymeric materials. The sections 46 b and48 b of the retainer 30 b may be formed of polymers or copolymers. It iscontemplated that the retainer 30 b may be formed of biodegradable ornonbiodegradable materials. In one specific instance, the retainer wasmade from Poly-L-lactic acid (PLLA) which is a resorbable polymer.

The suture 36 b may be formed by a single filament or a plurality offilaments. The suture 36 b may be formed of biodegradable ornonbiodegradable material. It is contemplated that it may be desired toform the suture 36 b of the same material as the retainer 30 b. However,the retainer 30 b and suture 36 b may be formed of different materials.

Although the foregoing description in the manner in which the retainer30 b and 36 b are positioned relative to body tissue have been inconjunction with manual positioning of the applicator assembly 172 by asurgeon, it is contemplated that a robotic mechanism may be utilized toposition the retainer 30 b and/or suture 36 b relative to body tissue.Thus, a robotic mechanism may be utilize in association with theretainer 30 b and/or suture 36 b in the manner described in theaforementioned U.S. patent application Ser. No. 10/102,413 filed Mar.20, 2002 by Peter M. Bonutti and entitled Methods of Securing BodyTissue. It is contemplated that imaging apparatus may be utilized inassociation with the positioning of the retainer 30 b and/or suture 36 bin the manner disclosed in the aforementioned U.S. patent applicationSer. No. 10/102,413 filed Mar. 20, 2002 by Peter M. Bonutti.

Embodiment of FIG. 18

In the embodiment of the invention illustrated in FIG. 18, one of thesections of the retainer has a recess which receives the other sectionof the retainer. Since the embodiment of the invention illustrated inFIG. 18 is generally similar to the embodiments of the inventionillustrated in FIGS. 1-8, and 14-17, similar numerals will be utilizedto designate similar components, the suffix letter “c” being associatedwith the numerals of FIG. 18 to avoid confusion.

A retainer 30 c (FIG. 18) includes a lower or base section 46 c and anupper or cover section 48 c. A suture 36 c has portions 32 c and 34 cwhich extend through the retainer 30 c. An intermediate portion 38 c ofthe suture may extend around body tissue in the manner disclosed inFIG. 1. Of course, the suture 36 c may be connected with either hard orsoft body tissue in any desired manner.

The lower section 46 c of the retainer 30 c has a cylindrical recess 274which is sized so as to receive the circular upper section 48 c of theretainer 30 c. The lower section 46 c of the retainer has passages 278and 280 through which the portion 32 c of the suture 36 c extends. Inaddition, the lower section 46 c of the retainer 30 c has passages 282and 284 through which the portion 34 c of the suture 36 c extends. Therecess 274 cooperates with the passages 278,280, 282 and 284 to form acentral passage through which both portions 32 c and 34 c of the sutureextend.

A pair of projections 288 and 290 extend from the upper section 48 c ofthe retainer 30 c toward the lower section 46 c of the retainer. Theprojections 288 and 290 have pointed end portions 292 and 294 whichfunction as energy directors and concentrate ultrasonic vibratory energytransmitted from the applicator assembly 172 (FIG. 9) to the uppersection 48 c of the retainer 30 c. The projections 288 and 290 areoffset from the portions of the suture 36 c. One of the projections, forexample, the projection 288, may be offset in a direction into the pageon which FIG. 18 is disposed and the other projection, that is theprojection 290, may be offset in a direction out of the page on whichFIG. 18 is disposed.

When the suture 36 c and retainer 30 c are to be utilized in associationwith body tissue, the suture 36 c is positioned relative to the bodytissue. The portion 32 c of the suture 36 c is then moved through thepassages 278 and 280 in the lower section 46 c of the retainer 30 c. Theportion 34 c of the suture 36 c is moved through the passages 282 and284 of the lower section 46 c of the retainer 30 c.

The upper section 48 c of the retainer 30 c is then positioned in therecess 274 with the projections 288 and 290 disposed in linearengagement with a flat upwardly facing side surface 298 on the lowersection 46 c of the retainer 30 c. The pointed ends of the projections292 and 294 do not engage the suture 36 c The retainer 30 c is grippedby the distal end portion (FIG. 12) of the applicator assembly 172. Thisresults in the retainer 30 c being gripped with a constant predeterminedforce transmitted to the retainer 30 c from the biasing spring 180 (FIG.9) through the force transmitting member 176.

While the surgeon grips the handle 194 of the applicator assembly 172with one hand and grips the portions 32 c and 34 c of the suture 36 cwith the other hand, the retainer 30 c and leading end portion of theapplicator assembly 172 are moved toward the body tissue. As thisoccurs, the retainer 30 c is slid along the portions 32 c and 34 c ofthe suture 36 c. While the retainer 30 c is slid along the suture 36 c,the retainer is gripped with a constant predetermined force by theapplicator assembly 172.

When the retainer 30 c is positioned in a desired location relative tothe suture 36 c and body tissue, energy is transmitted from theapplicator assembly 172 to the retainer 30 c to interconnect the lowersection 46 c and upper section 48 c of the retainer 30 c. During thetransmission of energy to the retainer 30 c to interconnect the lowersection 46 c and upper section 48 c of the retainer, the applicatorassembly 172 applies a constant predetermined clamping or gripping forceto the retainer 30 c. Ultrasonic vibratory energy is transmitted fromthe end surface 206 on the energy transmission member 174 to the uppersection 48 c of the retainer 30 c. The pointed end portions 292 and 294of the projections 288 and 290 engage the flat side surface 298 on thelower section 46 c of the retainer. The pointed end portions 292 and 294of the projection 288 act as energy directors which concentrate energyat the pointed end portions of the projections and at the portion of thesurface 298 and engaged by the projections.

This energy heats the projections 288 and 290 and portions of the lowersection 46 c into a transition temperature range. As this occurs, thematerial of the projections 288 and 290 softens and flows relative tothe suture 36 c and lower and upper sections 46 c and 48 c of theretainer 30 c. The lower and upper sections 46 c and 48 c of theretainer 30 c are clamped together with a constant predetermined forceby the applicator assembly 172 as the material of the projections 288and 290 is heated. The lower and upper sections 46 c and 48 c of theretainer 30 c grip the suture 36 c with a clamping action.

Material of the retainer 36 c is subsequently allowed to cool and thetrigger 198 on the applicator assembly 172 is actuated to releaseretainer 30 c. As the material of the retainer 30 c cools, the lowersection 46 c and upper section 48 c of the retainer are bonded together.In addition, there is some bonding of the material of the retainer 30 cto the suture 36 c. However, the suture 36 c is primarily securedagainst movement relative the retainer 30 c by clamping the portions 32c and 34 c of the suture 36 c between the lower section 46 c and theupper section 48 c of the retainer 30 c. Although the suture 36 c isslightly deformed, in the manner illustrated schematically in FIG. 8,there is no significant weakening of the suture 36 c.

It is contemplated that the suture 36 c and retainer 30 c may bepositioned relative to body tissue during minimally invasive surgery.The suture 36 c and retainer 30 c may be positioned relative to the bodytissue by being moved through a cannula. If desired, a robotic mechanismmay be utilized to position the suture 36 c and/or retainer 30 crelative to the body tissue.

In the embodiment of the invention illustrated in FIG. 18, the uppersection 48 c of the retainer 30 c is separate from the lower section 46c and is manually moved into the recess 274 after the portions 32 c and34 c of the suture 36 c have been positioned in the passages 278, 280,282 and 284. If desired, the upper section 48 c of the retainer 30 ccould be connected with the lower section 46 c. For example, the uppersection 48 c may be positioned in the recess 274. An interference fitmay be provided between the lower and upper sections 46 c and 48 c tohold the upper section in the recess 274. Alternatively, one or moreflexible connectors may be used to interconnect the lower and uppersections. The connector may be a flexible strap. If desired, theconnector may be weak sections which are easily broken as the uppersection 48 c moves into the recess 274.

Embodiment of FIG. 19

In the embodiments of the invention illustrated in FIGS. 1-8 and 14-18,the suture 36 extends through passages in the retainer 30 and is clampedin place. In the embodiment of the invention illustrated in FIG. 19, thesuture extends through passages in the retainer and is wrapped around aportion of the retainer, in a manner similar to that previouslydescribed in conjunction with the embodiment of the inventionillustrated in FIG. 13, prior to being clamped in place byinterconnecting of the lower and upper sections of the retainer. Sincethe embodiment of the invention illustrated in FIG. 19 is generallysimilar to the embodiments of the invention illustrated in FIGS. 1-8 and14-18, similar numerals will be utilized to indicate similar components,the suffix letter “d” being associated with the numerals of FIG. 19 toavoid confusion.

A retainer 30 d is associated with a suture 36 d. The retainer 30 d hasa lower section 46 d and an upper section 48 d. The suture 36 d has aportion 32 d and a portion 34 d which extend through the retainer 30 d.An intermediate portion 38 d of the suture 36 d extends between theportions 32 d and 34 d of the suture and may extend around body tissuein the manner illustrated schematically for the suture 36 in FIG. 1.

The lower section 46 d of the retainer 30 d has a cylindrical centralprojection or post 310. The portion 32 d of the suture 36 d extendsthrough a passage 314 in the lower section 46 d of the retainer 30 d andis looped for a plurality of turns around the central projection 310.The portion 32 d of the suture 36 d extends from the loops around thecentral projection 310 through a passage 316 in the upper section 48 dof the retainer 30 d. Similarly, the portion 34 d of the suture 36 dextends through a passage 320 in the lower section 46 d and is wrappedfor a plurality of loops around the central projection 310. The portion34 d of the suture 36 d extends from the central projection 310 througha passage 322 in the upper section 48 d of the retainer 30 d.

Projections 324 and 326 extend downward (as viewed in FIG. 19) from theupper section 48 d toward a flat upper side surface 330 on the lowersection 46 d. The projections 324 and 326 are offset from the centralprojection 310 and from the openings 314 and 320 in the lower section 46d. Although only two projections 324 and 326 are illustrated in FIG. 19,a greater number of projections may be provided if desired.

The suture 36 d is positioned relative to body tissue in the same manneras is illustrated schematically for the suture 36 in FIG. 1. This may bedone during arthroscopic or laproscopic surgery. To minimize the size ofan incision in a patient's body, the suture may be moved through acannula into the patient's body and positioned relative to hard and/orsoft body tissue. The portions 32 d and 34 d of the suture may extendfrom the cannula and be readily accessible to a surgeon.

The portion 32 d of the suture is inserted through the passage 314 andwrapped for a plurality of turns around the central projection 310. Theportion 34 d of the suture is inserted through the passage 320 and isalso wrapped for a plurality of turns around the central projection 310.The portion 34 d of the suture is inserted through the passage 322 inthe upper section 48 d of the retainer 30 d. The portion 32 d of thesuture 36 d is inserted through the passage 316 in the upper section 48d of the retainer 30 d.

The upper section 48 d of the retainer 30 d is moved along the portions32 d and 34 d of the suture until the projections 324 and 326 from theupper section 48 d of the retainer 30 d engage the flat upper sidesurface 330 of the lower section 46 d of the retainer. As this occurs,the central projection 310 enters a cylindrical opening 334 in the uppersection 48 d of the retainer 30 d. As the central projection 310 istelescopically inserted into the opening 334, the turns of the portions32 d and 34 d of the suture 36 d are disposed around the centralprojection move downward (as viewed in FIG. 19) toward the flat surface330 on the lower section 46 d of the retainer 30 d.

The projections 324 and 326 are offset from the portions 32 d and 34 dof the suture 36 d. The pointed projections 324 and 326 engage the flatsurface 330 on the lower section 46 d of the retainer 30 d. Theprojections 324 and 326 are spaced from the suture 36 d and prevent thesuture from being gripped between the lower section 46 d and uppersection 48 d of the retainer 30 d.

The retainer 30 d is then gripped by the distal end portion of theapplicator assembly 172 (FIG. 12). The applicator assembly 172 grips theretainer 30 d with a constant force which is determined by the spring180 (FIG. 9).

While the retainer 30 d is gripped by the applicator assembly 172, theretainer is slid along the portions 32 d and 34 d (FIG. 19) of thesuture 36 d toward the body tissue. As this occurs, the distal endportion of the applicator assembly 172 and the retainer 30 d may bemoved through a cannula or through an open incision. Regardless ofwhether or not the retainer 30 d is moved through a cannula, theretainer is positioned in engagement with body tissue, similar to thebody tissue of 40 of FIG. 1, while the retainer is gripped with thepredetermined constant force by the applicator assembly 172.

Once the retainer 30 d has been positioned relative to the body tissue,the portions 32 d and 34 d of the suture 36 d are tensioned with apredetermined force. While the suture 36 d is tensioned with apredetermined force, ultrasonic vibratory energy is transmitted from asource of energy, corresponding to the energy source 212 of FIG. 9, tothe retainer 30 d. The energy is transmitted to the retainer 30 dthrough the energy transmission member 174. The energy transmitted tothe retainer 30 d heats the projections 324 and 326 and the material ofthe lower section 46 d of the retainer engaged by the projections.

The projections 324 and 326 have a pointed configuration and function asenergy directors which concentrate the energy transmitted from thesource 212. This results in heating of the projections 324 and 326 and aportion of the lower section 46 d of the retainer 30 d engaged by theprojections to temperatures in the transition temperature range of thematerial of the retainer 30 d. As this occurs, the lower and uppersections 46 d and 48 d of the retainer 30 d are moved together under theinfluence of the constant predetermined force applied against theretainer by the applicator assembly 172. This results in the loops ofthe suture disposed around the central projection 310 being firmlygripped between the flat upper side surface 330 of the lower section 46d of the retainer and a flat lower side surface 338 on the upper section48 d of the retainer.

The trigger 198 on the applicator assembly 172 is then manually actuatedto release the retainer 30 d. As this occurs, the retainer 30 d cools. Asecure bond is formed between the lower section 46 d and upper section48 d of the retainer at the locations where the projections 324 and 326from the upper section 48 d of the retainer engage the lower section 46d of the retainer. A robotic mechanism may be utilized to position thesuture 36 d and/or retainer 30 d relative to body tissue.

It is contemplated that the retainer 30 d and suture 36 d may be formedof either biodegradable or nonbiodegradable material. The retainer 30 dand suture 36 d may be formed of the same materials or of differentmaterials. For example, the suture 36 d could be formed of abiodegradable material while the retainer 30 d is formed of anonbiodegradable material. Alternatively, both the suture 36 d andretainer 30 d may be formed of a biodegradable material.

Embodiment of FIGS. 20 and 21

In the embodiment of the invention illustrated in FIGS. 20 and 21, asuture is clamped between and held by sections of a retainer. Since theembodiment of the invention illustrated in FIGS. 20 and 21 is generallysimilar to the embodiments of the invention illustrated in FIGS. 1-8 and13-19, similar numerals will be utilized to designate similarcomponents, the suffix letter “e” being associated with the numerals ofFIGS. 20 and 21 to avoid confusion.

A retainer 30 e includes lower and upper sections 46 e and 48 e. Asuture 36 e (FIG. 20) has portions 32 e and 34 e which extend throughthe retainer 30 e. The portions 32 e and 34 e of the suture 36 e areinterconnected by an intermediate portion 38 e of the suture. A loop 230e is formed in the portion 32 e of the suture 36 e and extends aroundpart of the lower section 46 e of the retainer 30 e. Similarly, a loop232 e is formed in the portion 34 e of the suture 36 e and extendsaround part of the lower section 46 e of the retainer 30 e.

The lower section 46 e of the retainer 30 e includes a circular bottomwall 344 (FIG. 21) having a flat upwardly facing side surface 346. Acylindrical side wall 350 extends upward from the bottom wall 344. Theside wall 350 cooperates with the bottom wall 344 to form a cylindricalrecess 274 e (FIG. 21). The upper section 48 e has a circular body 64 ewhich has a diameter which is only slightly greater than an insidediameter cylindrical side wall 350 e. This results in an interferencefit between the upper section 48 e and lower section 46 e of theretainer 30 e when the upper section 64 e is inserted into thecylindrical recess 274 e.

While the upper section 48 e is held in the cylindrical recess 274 e inthe lower section 46 e of the retainer 30 e, the portions 32 e and 34 eof the suture 36 e are inserted through the retainer 30 e in oppositedirections. Thus, the suture 32 e is inserted through a passage 354(FIG. 20) in the side wall 350 of the lower section 46 e of the retainer30 e. The portion 32 e of the suture is inserted through the recess 274e (FIG. 21) to a second passage 356 formed in the side wall 350 of thelower section 46 e of the retainer.

The suture is wrapped around the outside of the side wall 350 andinserted through the passage 354 for a second time. The end portion 32 eof the suture 36 e is then moved through the passage 356 e in the sidewall for a second time. This forms the loop 230 e around a portion ofthe side wall 350 in the manner illustrated schematically in FIG. 20.

Similarly, the portion 34 e of the suture 36 e is inserted through apassage 360 formed in the side wall 350 (FIGS. 20 and 21) into thecylindrical recess 274 e. The portion 34 e of the suture is insertedthrough the cylindrical recess 274 e and through another passage 362formed in the side wall 350 of the lower section 46 e of the retainer 30e. The portion 34 e of the suture 36 e is wrapped around the outside ofthe side wall 350 (FIG. 20) and inserted for a second time through thepassage 360. The portion 34 e of the suture is inserted through therecess 274 e and the opening 362 e to form the loop 232 e around theportion of the lower section 46 e of the retainer 30 e.

The upper section 48 e of the retainer 30 e has a plurality of pointedprojections 366 and 368 (FIG. 20). When the upper section 48 e of theretainer 30 e is disposed in the recess 274 e, the projections 366 and368 are enclosed by the loops 230 e and 232 e. The projections 366 and368 have pointed end portions with a configuration similar to theconfiguration of the pointed end portions 124 and 126 on the projections66 and 68 of FIGS. 3-7. The end portions of the projections 366 and 368engage the side surface 346 on the bottom wall 344 when the uppersection 48 e is disposed in the cylindrical recess 274 e. There is linecontact between the end portions of the projections 366 and 368 and thesurface 346 on the bottom wall 344. The pointed end portions of theprojections 366 and 368 are spaced from the suture 36 e.

The upper section 48 e of the retainer 30 e has a second plurality ofprojections 374 and 376 (FIGS. 20 and 21). The projections 374 and 376have the same configurations as the projections 366 and 368. Theprojections 374 and 376 have pointed end portions 378 and 380 (FIG. 21).The pointed end portions 378 and 380 on the projections 374 and 376engage the flat side surface 346 on the bottom wall 344 when the uppersection 48 e of the retainer 30 e is disposed in the cylindrical recess274 e. The projections 374 and 376 are disposed within the loop 332 eformed in the portion 34 e of the suture 36 e. The pointed end portionsof the projections 374 and 376 are spaced from the suture 36 e.

When the retainer 30 e and suture 36 e are to be used to secure bodytissue during a surgical procedure, the intermediate portion 38 e of thesuture is positioned relative to the body tissue. At this time, theupper section 48 e of the retainer 30 e is disposed in the cylindricalrecess 274 e in the lower section 46 e and the projections 366, 368, 374and 376 are disposed in engagement with the side surface 246 of thebottom wall 344 of the retainer. The upper section 48 e of the retainer30 e is held in the recess 274 e by an interference fit between acylindrical inner side surface of the side wall 350 and an outer sidesurface of the body 64 e of the upper section.

After the intermediate portion 38 e of the suture 36 e has beenpositioned relative to body tissue, the portion 32 e of the suture ismoved downward (as viewed in FIG. 20) through the passage 354 and alongthe projections 366 and 368. The portion 32 e of the suture 36 e is thenmoved through the passage 356 and wrapped around the outside of theretainer 30 e. The portion 32 e of the suture is again moved downward(as viewed in FIG. 20) through the passages 354 and 356 to form the loop230 e.

The portion 34 e of the suture 36 e is inserted upward (as viewed inFIG. 20) through the passage 360 and along the projections 374 and 376.The portion 34 e of the suture is then moved through the passage 362 andwrapped around the outside of the bottom section 46 e of the retainer 30e. The portion 34 e of the suture is again upward (as viewed in FIG. 20)through the passages 360 and 362 to form the loop 232 e. When this hasbeen done, the portions 32 e and 34 e of the suture extend in oppositedirections from the retainer 30 e and the intermediate portion 38 e ofthe suture extends in opposite directions from the retainer.

The retainer is then gripped with the distal end portion (FIG. 12) ofthe applicator assembly 172. The applicator assembly 172 grips theretainer 30 e with a constant predetermined force.

While the retainer 30 e is gripped with a constant predetermined forceby the applicator assembly 172, a surgeon manually holds the handle 194of the applicator assembly 172 (FIGS. 9 and 10) with one hand andtensions the portions 32 e and 34 e of the suture 36 e with the otherhand. While tensioning the suture 36 e, the surgeon slides the retainer30 e along the suture toward the body tissue. As it was previouslymentioned, this may involve moving of the retainer 30 e and the distalend portion of the applicator assembly 172 through a cannula to positionthe retainer relative to the body tissue. A robotic mechanism may beutilized to position the suture 36 e and/or retainer 30 e relative tobody tissue.

When the retainer has been positioned at a desired location relative tothe body tissue in the manner similar to the schematic illustration ofFIG. 1, energy is transmitted from the energy source 212 through theenergy transmission member 174 to the retainer 30 e. Although the energyis ultrasonic vibratory energy, it is contemplated that it could be adifferent type of energy if desired. For example, radio frequency,light, or thermal energy could be transmitted to the retainer 30 e.

The ultrasonic vibratory energy transmitted to the retainer 30 e isconcentrated by the projections 366, 368, 374 and 376 which function asenergy directors. The concentrated energy heats the projections 366,368, 374 and 376 and the portion of the bottom wall 344 of the lowersection 46 e of the retainer 30 e engaged by the projections, to atemperature in a transition temperature range for the material of theretainer. The retainer may be formed of a polymeric material which is apolymer or copolymer. The material of the retainer 30 e may bebiodegradable or nonbiodegradable.

As the projections 374 and 376 are heated and softened, the uppersection 48 e of the retainer is pressed toward the bottom wall 344 ofthe lower section 46 e of the retainer 30 e by the applicator assembly172. The force applied against the retainer 30 e is effective to causethe softened material of the projections 366, 368, 374 and 376 to flowin the recess 274 e. As this occurs, the upper section 48 e of theretainer 30 e moves toward the bottom wall 344 of the lower section 46 eof the retainer. This results in the portions 32 e and 34 e of thesuture 36 e being securely clamped between the lower section 46 e andupper section 48 e of the retainer 30 e.

When the material of the projections 374 and 376 has cooled, the lowersection 46 e and upper section 48 e of the retainer are securely bondedtogether to maintain a secure grip on the suture 36 e. Although theremay be some bonding of the material of the projections 366, 368, 374 and376 to the suture 36 e, there is no significant weakening of the suture.

Embodiment of FIG. 22

The retainer of the embodiment of the invention illustrated in FIG. 22is generally similar to the retainers of FIGS. 1-8 and 13-21. Numeralssimilar to the numerals utilized in conjunction with FIGS. 1-8 and 13-21will be utilized to designate similar components, the suffix letter “f”being associated with the numerals of FIG. 22 to avoid confusion.

A retainer 30 f has a lower section 46 f and an upper section 48 f. Asuture 36 f has portions 32 f and 34 f which extend through the retainer30 f. An intermediate portion 38 f of the suture 36 f extends betweenthe portions 32 f and 34 f and may extend around body tissue in themanner illustrated schematically in FIG. 1 for the suture 36.

The portion 32 f of the suture 36 f extends through a passage 384 in thelower section 46 f of the retainer 30 f. The portion 32 f of the sutureextends through a passage 386 formed in the upper section 48 f of theretainer 30 f. The portion 32 f of the suture is wrapped around aportion 390 of the upper section 48 f of the retainer 30 f. The portion32 f of the suture is again inserted through the passage 386 to form aloop 230 f around the portion 390 of the upper section 48 f of theretainer 30 f.

Similarly, the portion 34 f of the suture 36 f extends through a passage394 in the lower section 46 f of the retainer 30 f. The portion 34 f ofthe suture 36 f extends through a passage 396 in the upper portion 48 fof the retainer 30 f. The portion 34 f of the suture 36 f is wrappedaround a portion 398 of the upper section 48 f of the retainer 30 f toform a loop 232 f.

Projection 400 extends from the upper section 48 f of the retainer 30 f.The projection 400 is engagable with a flat upper side surface 402 ofthe lower section 46 f of the retainer 30 f. The projection 400 has apointed end portion which functions as an energy director whichconcentrates energy.

When the retainer 30 f and suture 36 f are utilized to secure bodytissue, in a manner similar to that manner illustrated schematically inFIG. 1, the suture 36 f is positioned relative to the body tissue withthe intermediate portion 38 f of the suture in engagement with the bodytissue. The portion 32 f of the suture is inserted through the passages384 and 386 in the lower and upper sections 46 f and 48 f of theretainer 30 f. The portion 32 f of the suture is then wrapped around theportion 390 of the upper section 48 f of the retainer 30 f and againinserted through the passage 386.

The portion 34 f of the suture 36 f is inserted through the passage 394in the lower section 46 f of the retainer 30 f and through the passage396 in the upper section 48 f of the retainer. The portion 34 f of thesuture 36 f is wrapped around the portion 398 of the upper section 48 fof the retainer 30 f and again inserted through the passage 396.

The retainer 40 f is then gripped by the distal end portion (FIG. 12) ofthe applicator assembly 172 (FIGS. 9 and 10). This results in theprojection 400 being pressed against the upper side surface 402 of thelower section 46 f of the retainer 30 f with a predetermined constantforce. While the retainer 30 f is gripped by the distal end portion ofthe applicator assembly 172, a surgeon grips the portions 32 f and 34 fof the suture 36 f with one hand and grips the handle 194 of theapplicator assembly 172 with the other hand. While tensioning theportions 32 f and 34 f, the surgeon slides the retainer 30 f along thesuture 36 f toward the body tissue. As it was previously mentioned, thismay involve moving both the retainer 30 f and the distal end portion ofthe applicator assembly 172 through a cannula.

A robotic mechanism may be utilized to position the suture 36 f and/orretainer 30 f relative to body tissue. Alternatively, the suture 36 fand/or retainer 30 f may be manually positioned relative to the bodytissue.

Once the retainer 30 f has been positioned relative to body tissue,energy is transmitted from a source 212 (FIG. 9) through the energytransmission member 174 to the retainer 30 f. The pointed projection 400functions as energy director and is effective to concentrate theultrasonic vibratory energy in the projection 400 and in the portion ofthe lower section 48 f of the retainer 30 f engaged by the projection400. The energy transmitted to the retainer 30 f is effective to heatthe projection 400 and the portion of the lower section 46 f of theretainer engaged by the projection, into the transition temperaturerange for the material of the retainer 30 f.

Once the material of the retainer 30 f has been heat softened, thematerial can flow under the influence of the constant predeterminedforce with which the applicator assembly 172 grips the retainer 30 f.This results in deformation of the projection 400 and movement of thelower and upper sections 46 f and 48 f of the retainer 30 f together toclamp the portions 32 f and 34 f of the suture 36 f between the flatupper side surface of the lower section 46 f and flat lower side surface404 of the upper section 48 f of the retainer.

When the material of the retainer 30 f has cooled, the trigger 198 onthe applicator assembly 172 is actuated and the retainer is released.The lower and upper sections 46 f and 48 f of the retainer 30 f arebonded together and maintain the clamping action against the portions 32f and 34 f of the suture 36 f to prevent relative movement between theretainer 30 f and the suture 36.

Although only a single projection 400 has been illustrated schematicallyin FIG. 22, it should be understood that a plurality of projections maybe provided. This would result in bonds being formed between the lowerand upper section 46 f and 48 f of the retainer 30 f at each of aplurality of projections.

Embodiment of FIG. 23

The embodiment of the invention illustrated in FIG. 23 is generallysimilar to the embodiments of FIGS. 1-8 and 13-22. Therefore, similarnumerals will be utilized to designate similar components, the suffixletter “g” being associated with the numerals of FIG. 23 to avoidconfusion.

A retainer 30 g includes a lower section 46 g and an upper section 48 g.The retainer 30 g may be formed of a polymeric material which is eithera polymer or copolymer. The retainer 30 g may be biodegradable ornonbiodegradable.

A suture 36 g has a portion 32 g which extends through the retainer 30 gand a portion 34 g which also extends through the retainer. The suture36 g may be formed of a plurality of filaments or a single filament. Thesuture 36 g is formed of a polymeric material which is either a polymeror a copolymer. The suture 36 g may be formed of a material whichbiodegradable or of a material which is nonbiodegradable. The retainer30 g and suture 36 g may be formed of the same material or of differentmaterials.

When the retainer 30 g and suture 36 g are to be used to secure bodytissue, in a manner similar to the manner illustrated schematically inFIG. 1, an intermediate portion 38 g of the suture is positioned aroundbody tissue. The portions 32 g and 34 g of the suture 36 g are thenpositioned relative to the lower and upper sections 46 g and 48 g of theretainer 30 g.

When this is to be done, a portion 32 g of the suture 36 g is insertedthrough a passage 410 in the lower section 46 g of the retainer 30 g.The portion 32 g of the suture 36 g is wrapped around a portion 412 ofthe lower section 46 g of the retainer 30 g. The portion 32 g of thesuture is then inserted through the passage 410 for a second time formsa loop 230 g around the portion 412 of the lower section 46 g of theretainer 30 g. The portion 32 g of the suture 36 g is then insertedthrough a passage 414 in the upper section 48 g of the retainer 30 g.

Similarly, the portion 34 g of the suture 36 g is inserted through apassage 420 in the lower section 46 g of the retainer 30 g. The portion34 g of the suture 36 g is then wrapped around the portion 422 of thelower section 46 g to form a loop 232 g. The portion 34 g of the suture36 g is then inserted through the passage 420 for a second time. Theportion 34 g of the suture 36 g is then inserted through a passage 426in the upper section 48 g of the retainer 30 g.

The sections 46 g and 48 g of the retainer 30 g are then moved together.As this occurs, a projection 400 g from the upper section 48 g movesinto engagement with a flat upper side surface 402 g on the lowersection 46 g of the retainer 30 g. The retainer 30 g is then grippedwith the distal end portion (FIG. 12) of the applicator assembly 172.The applicator assembly 172 grips the retainer 30 g with a constantpredetermined force.

When the retainer 30 g and suture 36 g are to be utilized to secure bodytissue, in the manner similar to that illustrated schematically in FIG.1, the suture 36 g is positioned with the intermediate portion 38 g ofthe suture extending around the body tissue. The portions 32 g and 34 gof the suture 36 g are positioned relative to the upper and lowersections 46 g and 48 g in the manner previously described andillustrated schematically in FIG. 23.

While the surgeon grips the handle 194 of the applicator assembly 172with one hand and grips the portions 32 g and 34 g of the suture 36 gwith the other hand, the retainer 30 g is slid along the suture towardthe body tissue. As the retainer 30 g is slid along the suture 36 gtoward the body tissue, the retainer is gripped with a constantpredetermined force by the applicator assembly 172. When the retainer 30g has been moved to a desired position relative to the body tissue,energy is transmitted from the source 212 to the energy transmissionmember 174. Although many different types of energy may be utilized, theenergy transmitted to the retainer 30 g from the energy transmissionmember 174 is ultrasonic vibratory energy.

The projection 40 g has a pointed configuration and functions as anenergy director which concentrates the ultrasonic vibratory energytransmitted from the energy transmission member 174 to the retainer 30g. The projection 400 g and the material of the lower section 46 gengaged by the projection are heated into their transition temperatureranges. Heating of the materials of the projection 400 g into itstransition temperature range enables the material to flow under theinfluence of the constant predetermined force applied against theretainer 30 g by the applicator assembly 172. This results in the suture36 g being firmly clamped between the flat upper side surface 402 g ofthe lower section 46 g and a flat lower side surface 404 g of the uppersection 48 g of the retainer 30 g. The material of the projection 400 gbonds to the material of the lower section 46 g of the retainer 30 g.This results in the clamping force applied against the suture 36 g bythe lower and upper sections 46 g and 48 g of the retainer 30 g beingmaintained.

Although only a single projection 400 g has been illustratedschematically in FIG. 23, it is contemplated that a plurality ofprojections may be provided. Each of the projections from the uppersection 48 g of the retainer 30 g would engage the upper side surface402 g of the lower section 46 g of the retainer. This would result in aplurality of bonds being formed between the lower section 46 g and uppersection 48 g of the retainer.

Embodiment of FIG. 24

It is contemplated that the applicator assembly 172 (FIGS. 9-12) may beutilized to position any one of the retainers of FIGS. 1-8 and 13-23relative to body tissue 40. The applicator assembly 172 is operable tobond upper and lower sections of any one of the retainers disclosedherein together to maintain a secure grip on portions 32 and 34 of thesutures 36. It should be understood that the applicator assembly 172 maybe used with retainers other than the retainers disclosed herein.

In the embodiment of FIG. 24, the applicator assembly 172, retainer 30and suture 36 have been illustrated in associated with a cannula 450. Itshould be understood that the applicator assembly 172, suture 36 and anyone of the retainers 30 disclosed herein may be utilized without thecannula 450. However, by using the cannula 450, it is believed thatminimally invasive surgery will be facilitated. Of course, the suture36, retainer 30, and applicator assembly 172 may be utilized duringsurgical procedures which are not minimally invasive surgicalprocedures.

When the cannula 450 is to be utilized during a surgical procedure, thecannula is moved through body tissue 452 to a position in which a distalend portion 454 of the cannula 450 is adjacent to the body tissue 40 tobe engaged by the suture 36. The proximal end portion 456 of the cannula450 extends from the body tissue 452 in the manner illustratedschematically in FIG. 24. Once the cannula 450 has been positionedrelative to the body tissue 40, the suture 36 is moved through thecannula and positioned relative to the body tissue. The portions 32and/or 34 of the suture may be moved through the cannula 450 to positionthe suture relative to the body tissue. The portions 32 and/or 34 of thesuture are then pulled from the cannula 450 with the intermediateportion 38 of the suture engaging the body tissue 40.

The portions 32 and 34 of the suture 36 are then inserted through one ormore passages in the retainer 30. Once the portions 32 and 34 of thesuture have been inserted through the retainer 30, the retainer isgripped by the applicator assembly 172 in the manner illustratedschematically in FIG. 24. When the retainer 30 is gripped by theapplicator assembly 172, a constant predetermined force is appliedagainst the retainer 30 by the applicator assembly 172.

A surgeon may then manually grasp the portions 32 and 34 of the sutureand tension the suture. At the same time, the surgeon manually graspsthe handle 194 (FIG. 10) on the applicator assembly 172 and moves theapplicator assembly downward (as viewed in FIG. 24) toward the cannula450. As this occurs, the retainer 30 slides along the portions 32 and 34of the suture and approaches the proximal end portion 456 of the cannula450.

Continued movement of the applicator assembly 172 toward the body tissue40 slides the retainer 30 along the portions 32 and 34 of the suture 36as the leading end portion of the applicator assembly and retainer enterthe cannula. The downward (as viewed in FIG. 24) movement of theapplicator assembly 172 and retainer 30 is continued while tension ismaintained in the portions 32 and 34 of the suture 36. This results inthe retainer 30 sliding along the portions 32 and 34 of the suture 36 asthe retainer 30 is moved through the cannula 450 by the applicatorassembly 172.

The retainer 30 and leading end portion of the applicator assembly 172may be moved through the distal end portion 454 of the cannula 450 andpositioned in engagement with the body tissue 40. Alternatively, thedistal end portion 454 of the cannula may be placed in engagement withthe body tissue and the retainer moved into engagement with a surfacearea of the body tissue 40 which is surrounded by the distal end portion454 of the cannula 450.

Once the retainer 30 has been positioned at a desired location relativeto the body tissue 40, the portions 32 and 34 of the suture 36 aretensioned with a desired force. The manner in which the portions 32 and34 of the suture 36 are tensioned with a predetermined force may be thesame as is disclosed in U.S. Pat. No. 6,159,234 or in U.S. patentapplication Ser. No. 09/556,458 filed May 3, 2000 by Peter M. Bonuttiand entitled Method And Apparatus For Securing Tissue. Of course, apredetermined tension may be established in the portions 32 and 34 ofthe suture 36 in a different manner if desired.

While the predetermined tension is maintained in the portions 32 and 34of the suture, the switch 214 (FIG. 9) is closed and ultrasonicvibratory energy is conducted through the energy transmission member 174to the retainer 30. The ultrasonic vibratory energy is effective to heatpointed end portions of one or more projections on the retainer 30. Thisresults in a bonding between upper and lower sections of the retainer inthe manner previously described in conjunction with the retainers ofFIGS. 1-8 and 13-23.

The switch 214 is then released and the flow of ultrasonic vibratoryenergy to the retainer 30 is interrupted. When this occurs, the retainercools and an ultrasonic weld is formed between the sections of theretainer. The trigger 198 on the applicator assembly 172 is thenactuated to move the force transmitting member 176 axially downward (asviewed in FIG. 24) to release the retainer 30. When the applicatorassembly 172 has been disengaged from the retainer 30, it is removedfrom the cannula 450. The end portions 32 and 34 of the suture 36 maythen be cut to a desired length or connected with other body tissue.

Although in the specific embodiment of the invention illustrated in FIG.24 the suture 36 and retainer 30 are utilized in association with softbody tissue, it is contemplated that the suture 36 and retainer 30 maybe used in association with hard body tissue or with both hard and softbody tissue. It is contemplated that the suture 36 may be connected withbody tissue in known ways other than the specific way illustratedschematically in FIG. 24. The looping of the suture 36 around the bodytissue 40 in FIG. 24 is merely a representation of any one of the manyknown ways of connecting a suture with body tissue.

Rather than being manually actuated, the applicator assembly 172 mayform a portion a robotic mechanism. The robotic mechanism may beoperated to tension the suture 36 with a desired tension, slide theretainer 30 along the suture, and transmit energy to the retainer in themanner previously described in conjunction with the applicator assembly172. The robotic mechanism may be constructed and used in associationwith imaging devices in the same manner disclosed in U.S. patentapplication Ser. No. 10/102,413 filed Mar. 20, 2002 by Peter M. Bonuttiand entitled Methods of Securing Body Tissue. It is contemplated thatthe cannula 450 may have any one of many different known constructions,including the constructions disclosed in U.S. Pat. Nos. 6,338,730 and6,358,266.

Embodiment of FIG. 25

In the embodiment of the invention illustrated in FIG. 12, theapplicator assembly 172 is provided with a flange 204 which engages agroove 142 in a retainer 30. In addition, the distal end portion of theapplicator assembly 172 of FIGS. 9-12 is exposed so that a retainergripped between the flange 204 and the end surface 206 on thetransmission member 174 is exposed to body fluids. In the embodiment ofthe invention illustrated in FIG. 25, the distal end portion of theapplicator assembly is provided with an end plate rather than a flangeand a shield cooperates with the end plate to enclose the retainer.Since the embodiment of the invention illustrated in FIG. 25 isgenerally similar to the embodiment of the invention illustrated inFIGS. 9-12, similar numerals will be utilized to designate similarcomponents, the suffix letter “h” being associated with the numerals ofFIG. 25 to avoid confusion.

An applicator assembly 172 h (FIG. 25) includes a tubular forcetransmitting member 176 h. The tubular force transmitting member 176 hextends around and is coaxial with an energy transmission member 174 h.The energy transmission member 174 h has a circular end surface 206 hwhich is engagable with a retainer 30 in a manner similar to thatillustrated in FIG. 24.

The metal end plate 464 is connected with the force transmitting member176 h. The metal end plate 464 replaces the flange 204 of the embodimentof the applicator assembly 172 illustrated in FIGS. 9-12 and iseffective to apply force against the lower section of a retainer 30 inthe manner previously described in conjunction with the retainers ofFIGS. 1-8 and 13-23. The end plate 464 eliminates the necessity for thegroove 142 in the lower section 46 of the retainer 30 (FIGS. 3-7). Inaddition, the end plate 464 provides for a relatively even distributionof force against the retainer 30 as it is clamped between the forcetransmitting member 176 and energy transmission member 174 with aconstant predetermined force in the manner illustrated schematically inFIG. 24. The applicator assembly 172 h has the same general constructionand mode of operation as the applicator assembly 172 of FIGS. 9-12.

In accordance with a feature of the embodiment of the inventionillustrated in FIG. 25, a flexible shield 468 is connected with tubularforce transmitting member 176. The shield 468 cooperates with the endplate 464 to enclose a retainer 30 gripped between the energytransmission member 174 and the end plate. The proximal end portion 470of the shield 468 is fixedly connected to the tubular force transmittingmember 176. The distal end portion 472 of the shield 468 is free to moverelative to the end plate 464 and force transmitting member 176. Thisprovides access to the space between the end plate 464 and the endsurface 206 on the energy transmission member 174 h to position theretainer 30 between the end plate 464 and the end surface 206 h on theenergy transmission member 174 h.

The shield cooperates with the force transmitting member 176 h toenclose the retainer 30. This minimizes exposure of the retainer 30 tobody tissue and/or body fluids. However, the flexible material of theshield 468 enables the portions 32 and 34 of the suture 36 to extendfrom the distal end portion of the applicator assembly 172.

CONCLUSION

In view of the foregoing description, it is apparent that the presentinvention relates to a new and improved apparatus and method for use insecuring a suture 36. The suture 36 is positioned relative to sections46 and 48 of an improved retainer 30. The sections 46 and 48 of theretainer 30 are interconnected when the retainer has been positionedrelative to a patient's body tissue 40. The sections 46 and 48 of theretainer 30 may be bonded together by the application of energy to theretainer by an improved applicator assembly 172.

The improved retainer 30 may have one or more projections 66 and 68which engage one or more recesses 58 and 60 to position the sections 46and 48 of the retainer relative to each other. An interference fit maybe provided between one or more projections 66 and 68 and one or morerecesses 58 and 60 to hold the sections 46 and 48 of the retainer 30 ina desired spatial relationship. The projections 66 and 68 may havesurfaces 88 and 90 which at least partially define one or more passages52 and 54 and guide movement of one or more portions 32 and 34 of thesuture 36 relative 30 to the retainer. In addition, surfaces on theprojections may function to position the suture relative to theretainer.

The improved applicator assembly 172 may be used to apply energy to theretainer 30. Energy applied to the retainer 30 may effect bonding of endportions 124 and 126 of the projections 66 and 68 to bottom portions 118and 120 of recesses 68 and 60 in the retainer 30. The end portions 124and 126 of the projections 58 and 60 may function as energy directorswhich concentrate energy. If desired, one or more loops 230 and 232 maybe formed in the suture 36 around one or more of the projections 66 and68.

The applicator assembly may grip the retainer 30 with a predeterminedforce. While the applicator assembly 172 grips the retainer 30, theapplicator assembly may be utilized to slide the retainer along thesuture 36 to position the retainer relative to body tissue. While theapplicator assembly 172 is gripping the retainer 30, the applicatorassembly may apply energy to the retainer to effect bonding of sections46 and 48 of the retainer together. The applicator assembly 172 may beused to move the retainer 30 into a cannula 450 to engage tissue in apatient's body.

The present invention includes a plurality of different features whichmay be utilized in combination with each other or separately. Thevarious features of the invention may be used in combination withfeatures of the prior art. For example, the improved retainer 30 may beused with the improved applicator assembly 172 or with a prior artapplicator assembly. As another example, the improved applicatorassembly 172 may be used with the improved retainer 30 or a prior artretainer. As still another example, the retainer 30 may be moved througha cannula 450 to a desired position relative to body tissue or may bepositioned relative to the body tissue without being moved through acannula.

1. A method of securing a first implant to a second implant, the method comprising: implanting the first implant into a body of a patient, the first implant having an upper surface with a plurality of pores; implanting the second implant into the body of the patient, the second implant including a projection and wherein the step of implanting the second implant includes contacting the upper surface of the first implant with the projection of the second implant; applying ultrasonic energy to the second implant to thereby heat the material of the projection into its transition temperature range; and applying a force to the second implant such that the material flows into the plurality of pores to thereby interconnect the first and second implants.
 2. The method of claim 1 wherein the projection is configured and dimensioned to function as an energy director that concentrates the ultrasonic energy.
 3. The method of claim 2 wherein the material of the projection softens and deforms when heated into its transition temperature range.
 4. The method of claim 3 wherein the application of the force is initiated during the application of the ultrasonic energy.
 5. The method of claim 4 wherein the application of the force is continued after the application of the ultrasonic energy.
 6. The method of claim 5 wherein the material of the projection flows laterally into the plurality of pores. 